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Trial record 8 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00069108
Recruitment Status : Completed
First Posted : September 18, 2003
Results First Posted : February 24, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: 5 FU
Drug: Leucovorin
Drug: Oxaliplatin
Drug: capecitabine [Xeloda]
Enrollment 627
Recruitment Details The study was conducted from 09 Jul 2003 to 31 Aug 2006 at 87 centers in 19 countries.
Pre-assignment Details  
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks). Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Period Title: Overall Study
Started 313 314
Completed 100 95
Not Completed 213 219
Reason Not Completed
Withdrawal by Subject             5             9
Adverse Event             64             42
Death             6             6
Administration             15             4
Insufficient therapy             117             144
Violation criteria             1             4
Refused treatment             5             10
Arm/Group Title XELOX FOLFOX-4 Total
Hide Arm/Group Description Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks). Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks). Total of all reporting groups
Overall Number of Baseline Participants 313 314 627
Hide Baseline Analysis Population Description
All participants with written informed consent who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 313 participants 314 participants 627 participants
60.7  (9.91) 59.7  (10.55) 60.2  (10.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 314 participants 627 participants
Female
119
  38.0%
123
  39.2%
242
  38.6%
Male
194
  62.0%
191
  60.8%
385
  61.4%
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 251 252
Median (95% Confidence Interval)
Unit of Measure: days
154
(140 to 175)
168
(145 to 182)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population
Statistical Test of Hypothesis P-Value 0.00584
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.87 to 1.24
Estimation Comments The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population
2.Secondary Outcome
Title Progression Free Survival Based on Independent Review Committee Assessment
Hide Description Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 251 252
Median (95% Confidence Interval)
Unit of Measure: days
168
(139 to 183)
162
(141 to 179)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.
Statistical Test of Hypothesis P-Value 0.00223
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.74 to 1.17
Estimation Comments The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population
3.Secondary Outcome
Title Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
Hide Description Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Median (95% Confidence Interval)
Unit of Measure: days
145
(137 to 169)
152
(137 to 172)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.91 to 1.37
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Progression Free Survival Based on Treatment Analysis- Per Population
Hide Description Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 251 252
Median (95% Confidence Interval)
Unit of Measure: days
153
(139 to 172)
164
(142 to 175)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.95 to 1.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Best Overall Response, Investigators’ Assessments
Hide Description Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Measure Type: Number
Unit of Measure: participants
Investigator Assessed, Responders 63 55
Investigator assessed-CR 0 2
Investigator assessed-PR 63 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4028
Comments p-value is for difference between response rates.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.79 to 1.77
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Best Overall Response, Independent Review Committee Assessment
Hide Description Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Measure Type: Number
Unit of Measure: participants
IRC Assessed, Responders 48 39
IRC assessed-CR 0 0
IRC assessed-PR 48 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2911
Comments p-value is for difference between response rates.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.81 to 2.01
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Median (95% Confidence Interval)
Unit of Measure: days
363
(320 to 412)
382
(323 to 418)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.87 to 1.23
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time To Response
Hide Description Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Measure Type: Number
Unit of Measure: participants
Week 1-6 13 11
Week 7-12 26 23
Week 13-18 22 18
Week 19-24 2 3
9.Secondary Outcome
Title Duration Of Response
Hide Description Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 313 314
Median (95% Confidence Interval)
Unit of Measure: days
169
(142 to 192)
190
(161 to 206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.79 to 1.68
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time To Treatment Failure
Hide Description Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters.
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 311 308
Median (95% Confidence Interval)
Unit of Measure: days
125
(106 to 139)
121.5
(101 to 137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XELOX, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.81 to 1.12
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
Hide Description Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description:
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
Overall Number of Participants Analyzed 311 308
Measure Type: Number
Unit of Measure: participants
Serum Glutamic-Pyruvic Transaminase (SGPT) 90 110
Serum Glutamic Oxaloacetic Transaminase (SGOT) 193 174
Alkaline Phosphatase 184 201
Calcium (hyper) 7 9
Calcium (hypo ) 68 70
Glucose (hyper) 201 207
Glucose (hypo) 12 9
Granulocytes 1 6
Haemoglobin 216 240
Neutrophils 113 199
Neutrophils/Granulocytes 114 202
Platelets 168 212
Potassium (hyper) 17 26
Potassium (hypo) 68 92
Serum Albumin 116 138
Serum Creatinine 18 32
Sodium (hyper) 14 21
Sodium (hypo) 64 73
Total Bilirubin 107 95
White blood cell (WBC) 124 205
Time Frame Up to 3 years
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin and had a safety assessment performed post baseline.
 
Arm/Group Title XELOX FOLFOX-4
Hide Arm/Group Description Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks). Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
All-Cause Mortality
XELOX FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
XELOX FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   94/311 (30.23%)   97/308 (31.49%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  0/311 (0.00%)  11/308 (3.57%) 
Neutropenia  1  0/311 (0.00%)  6/308 (1.95%) 
Thrombocytopenia  1  2/311 (0.64%)  2/308 (0.65%) 
Anaemia  1  1/311 (0.32%)  0/308 (0.00%) 
Coagulopathy  1  1/311 (0.32%)  0/308 (0.00%) 
Warm type haemolytic anaemia  1  0/311 (0.00%)  1/308 (0.32%) 
Cardiac disorders     
Myocardial infarction  1  1/311 (0.32%)  1/308 (0.32%) 
Cardiac failure  1  0/311 (0.00%)  1/308 (0.32%) 
Ear and labyrinth disorders     
Vertigo  1  0/311 (0.00%)  1/308 (0.32%) 
Gastrointestinal disorders     
Diarrhoea  1  18/311 (5.79%)  3/308 (0.97%) 
Intestinal Obstruction  1  8/311 (2.57%)  4/308 (1.30%) 
Vomiting  1  9/311 (2.89%)  1/308 (0.32%) 
Abdominal pain  1  5/311 (1.61%)  4/308 (1.30%) 
Small intestinal obstruction  1  4/311 (1.29%)  1/308 (0.32%) 
Nausea  1  4/311 (1.29%)  0/308 (0.00%) 
Enteritis  1  3/311 (0.96%)  0/308 (0.00%) 
Constipation  1  2/311 (0.64%)  0/308 (0.00%) 
Gastrointestinal haemorrhage  1  0/311 (0.00%)  2/308 (0.65%) 
Rectal haemorrhage  1  1/311 (0.32%)  1/308 (0.32%) 
*Stomatitis all  1  0/311 (0.00%)  1/308 (0.32%) 
Anal fistula  1  0/311 (0.00%)  1/308 (0.32%) 
Abdominal pain upper  1  0/311 (0.00%)  1/308 (0.32%) 
Colitis  1  1/311 (0.32%)  0/308 (0.00%) 
Colonic pseudo-obstruction  1  1/311 (0.32%)  0/308 (0.00%) 
Colonic stenosis  1  0/311 (0.00%)  1/308 (0.32%) 
Haematemesis  1  1/311 (0.32%)  0/308 (0.00%) 
Ileus  1  1/311 (0.32%)  0/308 (0.00%) 
Ileus paralytic  1  0/311 (0.00%)  1/308 (0.32%) 
Large intestinal obstruction  1  0/311 (0.00%)  1/308 (0.32%) 
Lower gastrointestinal haemorrhage  1  0/311 (0.00%)  1/308 (0.32%) 
Melaena  1  0/311 (0.00%)  1/308 (0.32%) 
Pancreatitis acute  1  1/311 (0.32%)  0/308 (0.00%) 
General disorders     
Pyrexia  1  6/311 (1.93%)  9/308 (2.92%) 
Asthenia  1  1/311 (0.32%)  1/308 (0.32%) 
Catheter related complication  1  0/311 (0.00%)  2/308 (0.65%) 
Fatigue  1  1/311 (0.32%)  0/308 (0.00%) 
General physical health deterioration  1  0/311 (0.00%)  1/308 (0.32%) 
Pain  1  0/311 (0.00%)  1/308 (0.32%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  2/311 (0.64%)  0/308 (0.00%) 
Jaundice cholestatic  1  1/311 (0.32%)  1/308 (0.32%) 
Cholelithiasis  1  0/311 (0.00%)  1/308 (0.32%) 
Hepatic failure  1  1/311 (0.32%)  0/308 (0.00%) 
Hepatic pain  1  1/311 (0.32%)  0/308 (0.00%) 
Immune system disorders     
Hypersensitivity  1  0/311 (0.00%)  5/308 (1.62%) 
Infections and infestations     
Sepsis  1  2/311 (0.64%)  2/308 (0.65%) 
Infection  1  0/311 (0.00%)  3/308 (0.97%) 
Pneumonia  1  0/311 (0.00%)  3/308 (0.97%) 
Abdominal abscess  1  0/311 (0.00%)  2/308 (0.65%) 
Central line infection  1  2/311 (0.64%)  0/308 (0.00%) 
Escherichia bacteraemia  1  1/311 (0.32%)  1/308 (0.32%) 
Gastroenteritis  1  1/311 (0.32%)  1/308 (0.32%) 
Bacteraemia  1  1/311 (0.32%)  0/308 (0.00%) 
Bacterial sepsis  1  0/311 (0.00%)  1/308 (0.32%) 
Bronchopneumonia  1  0/311 (0.00%)  1/308 (0.32%) 
Clostridium difficile colitis  1  0/311 (0.00%)  1/308 (0.32%) 
Diarrhoea infectious  1  1/311 (0.32%)  0/308 (0.00%) 
Gastroenteritis salmonella  1  0/311 (0.00%)  1/308 (0.32%) 
Herpes zoster  1  0/311 (0.00%)  1/308 (0.32%) 
Influenza  1  0/311 (0.00%)  1/308 (0.32%) 
Parotitis  1  0/311 (0.00%)  1/308 (0.32%) 
Pelvic inflammatory disease  1  1/311 (0.32%)  0/308 (0.00%) 
Pneumonia pneumococcal  1  0/311 (0.00%)  1/308 (0.32%) 
Postoperative abscess  1  0/311 (0.00%)  1/308 (0.32%) 
Pyelonephritis acute  1  1/311 (0.32%)  0/308 (0.00%) 
Septic shock  1  0/311 (0.00%)  1/308 (0.32%) 
Sinusitis  1  0/311 (0.00%)  1/308 (0.32%) 
Streptococcal bacteraemia  1  1/311 (0.32%)  0/308 (0.00%) 
Upper respiratory tract infection  1  0/311 (0.00%)  1/308 (0.32%) 
Urinary tract infection  1  0/311 (0.00%)  1/308 (0.32%) 
Urosepsis  1  1/311 (0.32%)  0/308 (0.00%) 
Injury, poisoning and procedural complications     
Hand fracture  1  0/311 (0.00%)  1/308 (0.32%) 
Post procedural haemorrhage  1  1/311 (0.32%)  0/308 (0.00%) 
Subdural haematoma  1  0/311 (0.00%)  1/308 (0.32%) 
Thermal burn  1  0/311 (0.00%)  1/308 (0.32%) 
Transfusion reaction  1  0/311 (0.00%)  1/308 (0.32%) 
Investigations     
Weight decreased  1  1/311 (0.32%)  0/308 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  7/311 (2.25%)  5/308 (1.62%) 
Hyponatraemia  1  2/311 (0.64%)  0/308 (0.00%) 
Hypovolaemia  1  0/311 (0.00%)  2/308 (0.65%) 
Anorexia  1  0/311 (0.00%)  1/308 (0.32%) 
Hyperglycaemic hyperosmolar nonketotic syndrome  1  0/311 (0.00%)  1/308 (0.32%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/311 (0.64%)  2/308 (0.65%) 
Intervertebral disc protrusion  1  1/311 (0.32%)  0/308 (0.00%) 
Osteoporotic fracture  1  0/311 (0.00%)  1/308 (0.32%) 
Spinal disorder  1  0/311 (0.00%)  1/308 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Abdominal neoplasm  1  1/311 (0.32%)  0/308 (0.00%) 
Rectal neoplasm  1  1/311 (0.32%)  0/308 (0.00%) 
Nervous system disorders     
Convulsion  1  1/311 (0.32%)  0/308 (0.00%) 
Headache  1  0/311 (0.00%)  1/308 (0.32%) 
Lethargy  1  1/311 (0.32%)  0/308 (0.00%) 
Loss of consciousness  1  1/311 (0.32%)  0/308 (0.00%) 
Peripheral motor neuropathy  1  1/311 (0.32%)  0/308 (0.00%) 
Sciatica  1  0/311 (0.00%)  1/308 (0.32%) 
Vocal cord paralysis  1  0/311 (0.00%)  1/308 (0.32%) 
Psychiatric disorders     
Confusional state  1  1/311 (0.32%)  0/308 (0.00%) 
Mania  1  1/311 (0.32%)  0/308 (0.00%) 
Renal and urinary disorders     
Dysuria  1  1/311 (0.32%)  0/308 (0.00%) 
Hydronephrosis  1  1/311 (0.32%)  0/308 (0.00%) 
Renal failure acute  1  1/311 (0.32%)  0/308 (0.00%) 
Reproductive system and breast disorders     
Female genital tract fistula  1  1/311 (0.32%)  0/308 (0.00%) 
Pelvic pain  1  0/311 (0.00%)  1/308 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/311 (0.32%)  5/308 (1.62%) 
Dyspnoea  1  1/311 (0.32%)  2/308 (0.65%) 
Bronchospasm  1  0/311 (0.00%)  1/308 (0.32%) 
Cough  1  1/311 (0.32%)  0/308 (0.00%) 
Dysaesthesia pharynx  1  1/311 (0.32%)  0/308 (0.00%) 
Pleural effusion  1  0/311 (0.00%)  1/308 (0.32%) 
Surgical and medical procedures     
Analgesic therapy  1  0/311 (0.00%)  1/308 (0.32%) 
Urinary tract operation  1  1/311 (0.32%)  0/308 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  3/311 (0.96%)  3/308 (0.97%) 
Haematoma  1  1/311 (0.32%)  0/308 (0.00%) 
Peripheral ischaemia  1  1/311 (0.32%)  0/308 (0.00%) 
Superior vena caval occlusionq  1  0/311 (0.00%)  1/308 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XELOX FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   302/311 (97.11%)   298/308 (96.75%) 
Blood and lymphatic system disorders     
Neutropenia  1  56/311 (18.01%)  146/308 (47.40%) 
Thrombocytopenia  1  39/311 (12.54%)  51/308 (16.56%) 
Anaemia  1  19/311 (6.11%)  26/308 (8.44%) 
Gastrointestinal disorders     
Nausea  1  185/311 (59.49%)  172/308 (55.84%) 
Diarrhoea  1  168/311 (54.02%)  148/308 (48.05%) 
Vomiting  1  132/311 (42.44%)  105/308 (34.09%) 
Abdominal pain  1  92/311 (29.58%)  73/308 (23.70%) 
Stomatitis all  1  42/311 (13.50%)  92/308 (29.87%) 
Constipation  1  50/311 (16.08%)  79/308 (25.65%) 
Dyspepsia  1  34/311 (10.93%)  23/308 (7.47%) 
Abdominal pain upper  1  20/311 (6.43%)  18/308 (5.84%) 
General disorders     
Fatigue  1  127/311 (40.84%)  129/308 (41.88%) 
Asthenia  1  60/311 (19.29%)  56/308 (18.18%) 
Pyrexia  1  64/311 (20.58%)  68/308 (22.08%) 
Temperature intolerance  1  15/311 (4.82%)  21/308 (6.82%) 
Oedema peripheral  1  16/311 (5.14%)  28/308 (9.09%) 
Chills  1  9/311 (2.89%)  18/308 (5.84%) 
Infections and infestations     
Nasopharyngitis  1  14/311 (4.50%)  21/308 (6.82%) 
Investigations     
Weight decreased  1  19/311 (6.11%)  20/308 (6.49%) 
Metabolism and nutrition disorders     
Anorexia  1  98/311 (31.51%)  84/308 (27.27%) 
Hypokalaemia  1  24/311 (7.72%)  17/308 (5.52%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  32/311 (10.29%)  41/308 (13.31%) 
Pain in jaw  1  16/311 (5.14%)  12/308 (3.90%) 
Pain in extremity  1  19/311 (6.11%)  15/308 (4.87%) 
Myalgia  1  11/311 (3.54%)  21/308 (6.82%) 
Nervous system disorders     
Paraesthesia  1  103/311 (33.12%)  98/308 (31.82%) 
Peripheral sensory neuropathy  1  40/311 (12.86%)  50/308 (16.23%) 
Dysaesthesia  1  32/311 (10.29%)  34/308 (11.04%) 
Neuropathy peripheral  1  40/311 (12.86%)  30/308 (9.74%) 
Neuropathy  1  36/311 (11.58%)  29/308 (9.42%) 
Headache  1  32/311 (10.29%)  32/308 (10.39%) 
Hypoaesthesia  1  23/311 (7.40%)  20/308 (6.49%) 
Lethargy  1  18/311 (5.79%)  19/308 (6.17%) 
Dizziness  1  32/311 (10.29%)  29/308 (9.42%) 
Dysgeusia  1  22/311 (7.07%)  33/308 (10.71%) 
Psychiatric disorders     
Insomnia  1  21/311 (6.75%)  37/308 (12.01%) 
Respiratory, thoracic and mediastinal disorders     
Dysaesthesia pharynx  1  32/311 (10.29%)  13/308 (4.22%) 
Cough  1  21/311 (6.75%)  47/308 (15.26%) 
Dyspnoea  1  27/311 (8.68%)  30/308 (9.74%) 
Epistaxis  1  10/311 (3.22%)  22/308 (7.14%) 
Pharyngolaryngeal pain  1  10/311 (3.22%)  16/308 (5.19%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  71/311 (22.83%)  18/308 (5.84%) 
Rash  1  30/311 (9.65%)  22/308 (7.14%) 
Alopecia  1  4/311 (1.29%)  19/308 (6.17%) 
Vascular disorders     
Flushing  1  8/311 (2.57%)  19/308 (6.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069108     History of Changes
Other Study ID Numbers: NO16967
First Submitted: September 15, 2003
First Posted: September 18, 2003
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: April 1, 2016