A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

• ClinicalTrials.gov Identifier: NCT00069121
• Recruitment Status: Completed
• First Posted: September 18, 2003
• Results First Posted: July 29, 2011
• Last Update Posted: August 22, 2013
• Sponsor: Hoffmann-La Roche
• 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: capecitabine [Xeloda]; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5 FU
• Enrollment: 1886

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Period Title: Overall Study
Started	942	944
Received Treatment	926 [1]	938 [1]
Completed	640 [2]	668 [2]
Not Completed	302	276
Reason Not Completed
Death	225	197
Withdrawal by Subject	20	22
Lost to Follow-up	57	57
[1] Safety Population; [2] total includes Completed and Alive in follow-up

Baseline Characteristics

Arm/Group Title		5-FU/LV	XELOX	Total
Arm/Group Description		Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)	Total of all reporting groups
Overall Number of Baseline Participants		942	944	1886
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	942 participants	944 participants	1886 participants
		60.5 (10.76)	59.8 (10.95)	60.2 (10.86)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	942 participants	944 participants	1886 participants
	Female	442 46.9%	431 45.7%	873 46.3%
	Male	500 53.1%	513 54.3%	1013 53.7%

Outcome Measures

1. Primary Outcome

Title	Disease-free Survival (DFS) [Number of Events]
Description	Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.
Time Frame	Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Measure Type: Number; Unit of Measure: participants
Patients with event	353	295
Patients without events	589	649

2. Primary Outcome

Title	Disease-free Survival [Time to Event]
Description	Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
Time Frame	Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	67.9 [2]; (68 to NA)

[1]

The median time for DFS was not reached in this adjuvant trial.

[2]

The median time for DFS was not reached in this adjuvant trial; however, due to a late event in the XELOX arm and an artificial drop in the Kaplan-Meier estimate, an artificial median estimate for the XELOX groups appears.

3. Secondary Outcome

Title	Relapse-free Survival (RFS) [Number of Events]
Description	Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.
Time Frame	Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Measure Type: Number; Unit of Measure: participants
Patients with event	340	278
Patients without events	602	666

4. Secondary Outcome

Title	Relapse-free Survival (RFS) [Time to Event]
Description	Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.
Time Frame	Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	67.9 [2]; (68 to NA)

[1]

The median time for RFS was not reached in this adjuvant trial.

[2]

The median time for RFS was not reached in this adjuvant trial; however, due to a late event in the XELOX arm and an artificial drop in the Kaplan-Meier estimate, an artificial median estimate for the XELOX groups appears .

5. Secondary Outcome

Title	Overall Survival [Number of Events]
Description	Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Time Frame	Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Measure Type: Number; Unit of Measure: participants
Patients with event	225	197
Patients without events	717	747

6. Secondary Outcome

Title	Overall Survival [Time to Event]
Description	Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Time Frame	Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	5-FU/LV	XELOX
Arm/Group Description:	Given by one of two regimens.; Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	942	944
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

The median time to death was not reached in this adjuvant trial.

7. Secondary Outcome

Title	Number of Participants Assesed for Adverse Events
Description	Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline. See Adverse Events module for details.
Time Frame	followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	5-FU/LV MAYO CLINIC	5-FU/LV ROSWELL PARK	XELOX
Arm/Group Description:	Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)	Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)	Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed	657	269	938
Measure Type: Number; Unit of Measure: participants
	657	269	938

Adverse Events

Time Frame	Adverse Event Onset between Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake
Adverse Event Reporting Description	AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)
Arm/Group Title	5-FU/LV MAYO CLINIC	5-FU/LV ROSWELL PARK	XELOX
Arm/Group Description	5-fluorouracil/leucovorin	5-fluorouracil/leucovorin	Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
All-Cause Mortality
	5-FU/LV MAYO CLINIC	5-FU/LV ROSWELL PARK	XELOX
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	5-FU/LV MAYO CLINIC	5-FU/LV ROSWELL PARK	XELOX
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	134/657 (20.40%)	88/269 (32.71%)	208/938 (22.17%)
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA † 1	31/657 (4.72%)	2/269 (0.74%)	2/938 (0.21%)
NEUTROPENIA † 1	8/657 (1.22%)	2/269 (0.74%)	3/938 (0.32%)
ANAEMIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
COAGULOPATHY † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
HAEMOLYTIC URAEMIC SYNDROME † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
LEUKOPENIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
THROMBOCYTOPENIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Cardiac disorders
ATRIAL FIBRILLATION † 1	3/657 (0.46%)	1/269 (0.37%)	5/938 (0.53%)
ACUTE MYOCARDIAL INFARCTION † 1	0/657 (0.00%)	0/269 (0.00%)	3/938 (0.32%)
ANGINA PECTORIS † 1	2/657 (0.30%)	0/269 (0.00%)	1/938 (0.11%)
MYOCARDIAL INFARCTION † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
ANGINA UNSTABLE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ARRHYTHMIA SUPRAVENTRICULAR † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ATRIOVENTRICULAR BLOCK COMPLETE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CARDIAC ARREST † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
MYOCARDIAL ISCHAEMIA † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
PERICARDIAL EFFUSION † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
TACHYCARDIA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Ear and labyrinth disorders
VERTIGO POSITIONAL † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Eye disorders
EYE MOVEMENT DISORDER † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Gastrointestinal disorders
DIARRHOEA † 1	39/657 (5.94%)	24/269 (8.92%)	55/938 (5.86%)
STOMATITIS ALL † 1	22/657 (3.35%)	0/269 (0.00%)	2/938 (0.21%)
VOMITING † 1	6/657 (0.91%)	3/269 (1.12%)	15/938 (1.60%)
ABDOMINAL PAIN † 1	5/657 (0.76%)	3/269 (1.12%)	13/938 (1.39%)
INTESTINAL OBSTRUCTION † 1	5/657 (0.76%)	2/269 (0.74%)	7/938 (0.75%)
SMALL INTESTINAL OBSTRUCTION † 1	1/657 (0.15%)	3/269 (1.12%)	8/938 (0.85%)
ILEUS † 1	2/657 (0.30%)	4/269 (1.49%)	3/938 (0.32%)
NAUSEA † 1	3/657 (0.46%)	1/269 (0.37%)	4/938 (0.43%)
COLITIS † 1	1/657 (0.15%)	1/269 (0.37%)	3/938 (0.32%)
ENTERITIS † 1	2/657 (0.30%)	2/269 (0.74%)	1/938 (0.11%)
GASTROINTESTINAL HAEMORRHAGE † 1	0/657 (0.00%)	0/269 (0.00%)	4/938 (0.43%)
SUBILEUS † 1	1/657 (0.15%)	0/269 (0.00%)	3/938 (0.32%)
ABDOMINAL ADHESIONS † 1	0/657 (0.00%)	1/269 (0.37%)	1/938 (0.11%)
ENTEROCOLITIS † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
GASTRIC HAEMORRHAGE † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
GASTRITIS † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
GASTROINTESTINAL TOXICITY † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
HAEMATEMESIS † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
ILEITIS † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
INTESTINAL ISCHAEMIA † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
LARGE INTESTINAL OBSTRUCTION † 1	1/657 (0.15%)	1/269 (0.37%)	0/938 (0.00%)
NEUTROPENIC COLITIS † 1	1/657 (0.15%)	1/269 (0.37%)	0/938 (0.00%)
ABDOMINAL MASS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ASCITES † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
CAECITIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
COLITIS ISCHAEMIC † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
COLONIC FISTULA † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
CONSTIPATION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CROHN’S DISEASE † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
GASTRITIS EROSIVE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
GASTROINTESTINAL OBSTRUCTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
GASTROINTESTINAL OEDEMA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
GASTROINTESTINAL ULCER † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
GASTROOESOPHAGEAL REFLUX DISEASE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ILEUS PARALYTIC † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
INTERNAL HERNIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
INTESTINAL PERFORATION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
MECHANICAL ILEUS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
OESOPHAGEAL MASS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PERITONITIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
PNEUMATOSIS INTESTINALIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
SMALL INTESTINAL PERFORATION † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
UPPER GASTROINTESTINAL HAEMORRHAGE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
General disorders
PYREXIA † 1	2/657 (0.30%)	3/269 (1.12%)	12/938 (1.28%)
CHEST PAIN † 1	0/657 (0.00%)	1/269 (0.37%)	2/938 (0.21%)
GENERAL PHYSICAL HEALTH DETERIORATION † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
CHEST DISCOMFORT † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CHILLS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
DISEASE PROGRESSION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
FATIGUE † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
OEDEMA PERIPHERAL † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Hepatobiliary disorders
CHOLELITHIASIS † 1	0/657 (0.00%)	3/269 (1.12%)	0/938 (0.00%)
CHOLECYSTITIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
CHOLECYSTITIS ACUTE † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
HEPATIC LESION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PORTAL VEIN THROMBOSIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Immune system disorders
HYPERSENSITIVITY † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
ANAPHYLACTIC REACTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ANAPHYLACTOID REACTION † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
Infections and infestations
PNEUMONIA † 1	2/657 (0.30%)	1/269 (0.37%)	5/938 (0.53%)
SEPSIS † 1	3/657 (0.46%)	1/269 (0.37%)	3/938 (0.32%)
NEUTROPENIC SEPSIS † 1	5/657 (0.76%)	0/269 (0.00%)	0/938 (0.00%)
GASTROENTERITIS † 1	1/657 (0.15%)	2/269 (0.74%)	1/938 (0.11%)
BACTERAEMIA † 1	0/657 (0.00%)	0/269 (0.00%)	3/938 (0.32%)
CLOSTRIDIAL INFECTION † 1	1/657 (0.15%)	1/269 (0.37%)	1/938 (0.11%)
ANAL ABSCESS † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
INFECTION † 1	0/657 (0.00%)	1/269 (0.37%)	1/938 (0.11%)
SEPTIC SHOCK † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
ABDOMINAL ABSCESS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ABDOMINAL WALL ABSCESS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
BRONCHITIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
BRONCHOPNEUMONIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CELLULITIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CLOSTRIDIUM DIFFICILE COLITIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
DIVERTICULITIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ENDOPHTHALMITIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
HEPATITIS B † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
LOWER RESPIRATORY TRACT INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ORAL CANDIDIASIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
PHARYNGITIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
POSTOPERATIVE WOUND INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
RESPIRATORY TRACT INFECTION † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
SEPSIS SYNDROME † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
SKIN INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
STAPHYLOCOCCAL INFECTION † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
UPPER RESPIRATORY TRACT INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
URINARY TRACT INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
VIRAL INFECTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Injury, poisoning and procedural complications
FEMUR FRACTURE † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
ACCIDENTAL OVERDOSE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
INCISIONAL HERNIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PROCEDURAL SITE REACTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
SUBDURAL HAEMATOMA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
UPPER LIMB FRACTURE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
WOUND DEHISCENCE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Investigations
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
BLOOD BILIRUBIN ABNORMAL † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CULTURE STOOL POSITIVE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Metabolism and nutrition disorders
DEHYDRATION † 1	4/657 (0.61%)	10/269 (3.72%)	24/938 (2.56%)
HYPOKALAEMIA † 1	0/657 (0.00%)	0/269 (0.00%)	3/938 (0.32%)
ANOREXIA † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
HYPERGLYCAEMIA † 1	0/657 (0.00%)	1/269 (0.37%)	1/938 (0.11%)
ACIDOSIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
DIABETIC KETOACIDOSIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
FLUID OVERLOAD † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
HYPONATRAEMIA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Musculoskeletal and connective tissue disorders
ARTHRITIS † 1	1/657 (0.15%)	1/269 (0.37%)	0/938 (0.00%)
INTERVERTEBRAL DISC DISPLACEMENT † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
MYOSITIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Nervous system disorders
SYNCOPE † 1	2/657 (0.30%)	1/269 (0.37%)	1/938 (0.11%)
LOSS OF CONSCIOUSNESS † 1	0/657 (0.00%)	0/269 (0.00%)	3/938 (0.32%)
DIZZINESS † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
CEREBRAL AMYLOID ANGIOPATHY † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CEREBROVASCULAR ACCIDENT † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ENCEPHALOPATHY † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
HAEMORRHAGIC CEREBRAL INFARCTION † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
HEADACHE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
HEMIPLEGIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
ISCHAEMIC STROKE † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
NERVOUS SYSTEM DISORDER † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
NEUROPATHY PERIPHERAL † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PARAESTHESIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PERIPHERAL MOTOR NEUROPATHY † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PERIPHERAL SENSORY NEUROPATHY † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
SCIATICA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
SUPERIOR SAGITTAL SINUS THROMBOSIS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Psychiatric disorders
PSYCHOTIC DISORDER † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Renal and urinary disorders
RENAL FAILURE † 1	2/657 (0.30%)	0/269 (0.00%)	3/938 (0.32%)
HAEMATURIA † 1	1/657 (0.15%)	1/269 (0.37%)	1/938 (0.11%)
RENAL COLIC † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
RENAL FAILURE ACUTE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
URINARY RETENTION † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
UROGENITAL HAEMORRHAGE † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
Reproductive system and breast disorders
MENORRHAGIA † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
OVARIAN MASS † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
VAGINAL HAEMORRHAGE † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM † 1	4/657 (0.61%)	5/269 (1.86%)	3/938 (0.32%)
DYSPNOEA † 1	0/657 (0.00%)	0/269 (0.00%)	3/938 (0.32%)
DYSAESTHESIA PHARYNX † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
ASTHMA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
BRONCHOSPASM † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
EPISTAXIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
HAEMOPTYSIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
LARYNGOSPASM † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PNEUMONIA ASPIRATION † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
PNEUMOTHORAX † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
PULMONARY OEDEMA † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
RASH † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
Vascular disorders
DEEP VEIN THROMBOSIS † 1	3/657 (0.46%)	3/269 (1.12%)	5/938 (0.53%)
HYPOTENSION † 1	0/657 (0.00%)	1/269 (0.37%)	2/938 (0.21%)
THROMBOSIS † 1	1/657 (0.15%)	1/269 (0.37%)	1/938 (0.11%)
HYPERTENSION † 1	0/657 (0.00%)	0/269 (0.00%)	2/938 (0.21%)
THROMBOPHLEBITIS † 1	1/657 (0.15%)	0/269 (0.00%)	1/938 (0.11%)
ARTERIAL OCCLUSIVE DISEASE † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
HYPOVOLAEMIC SHOCK † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
JUGULAR VEIN THROMBOSIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
NECROSIS OF ARTERY † 1	1/657 (0.15%)	0/269 (0.00%)	0/938 (0.00%)
SUBCLAVIAN VEIN THROMBOSIS † 1	0/657 (0.00%)	1/269 (0.37%)	0/938 (0.00%)
VENA CAVA THROMBOSIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
VENOUS THROMBOSIS † 1	0/657 (0.00%)	0/269 (0.00%)	1/938 (0.11%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 12.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	5-FU/LV MAYO CLINIC	5-FU/LV ROSWELL PARK	XELOX
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	618/657 (94.06%)	262/269 (97.40%)	932/938 (99.36%)
Blood and lymphatic system disorders
NEUTROPENIA † 1	232/657 (35.31%)	36/269 (13.38%)	260/938 (27.72%)
THROMBOCYTOPENIA † 1	2/657 (0.30%)	4/269 (1.49%)	167/938 (17.80%)
ANAEMIA † 1	32/657 (4.87%)	36/269 (13.38%)	64/938 (6.82%)
FEBRILE NEUTROPENIA † 1	36/657 (5.48%)	3/269 (1.12%)	4/938 (0.43%)
Eye disorders
LACRIMATION INCREASED † 1	53/657 (8.07%)	49/269 (18.22%)	45/938 (4.80%)
Gastrointestinal disorders
DIARRHOEA † 1	449/657 (68.34%)	219/269 (81.41%)	577/938 (61.51%)
NAUSEA † 1	350/657 (53.27%)	190/269 (70.63%)	625/938 (66.63%)
STOMATITIS ALL † 1	419/657 (63.77%)	57/269 (21.19%)	195/938 (20.79%)
VOMITING † 1	142/657 (21.61%)	103/269 (38.29%)	415/938 (44.24%)
ABDOMINAL PAIN † 1	118/657 (17.96%)	92/269 (34.20%)	204/938 (21.75%)
CONSTIPATION † 1	82/657 (12.48%)	48/269 (17.84%)	187/938 (19.94%)
DYSPEPSIA † 1	38/657 (5.78%)	37/269 (13.75%)	87/938 (9.28%)
ABDOMINAL PAIN UPPER † 1	44/657 (6.70%)	21/269 (7.81%)	77/938 (8.21%)
FLATULENCE † 1	21/657 (3.20%)	29/269 (10.78%)	47/938 (5.01%)
DRY MOUTH † 1	23/657 (3.50%)	14/269 (5.20%)	26/938 (2.77%)
General disorders
FATIGUE † 1	148/657 (22.53%)	170/269 (63.20%)	332/938 (35.39%)
PYREXIA † 1	60/657 (9.13%)	43/269 (15.99%)	108/938 (11.51%)
TEMPERATURE INTOLERANCE † 1	0/657 (0.00%)	1/269 (0.37%)	104/938 (11.09%)
OEDEMA PERIPHERAL † 1	22/657 (3.35%)	29/269 (10.78%)	51/938 (5.44%)
CHILLS † 1	9/657 (1.37%)	16/269 (5.95%)	29/938 (3.09%)
Hepatobiliary disorders
ASTHENIA † 1	91/657 (13.85%)	44/269 (16.36%)	167/938 (17.80%)
Infections and infestations
NASOPHARYNGITIS † 1	20/657 (3.04%)	15/269 (5.58%)	32/938 (3.41%)
UPPER RESPIRATORY TRACT INFECTION † 1	13/657 (1.98%)	18/269 (6.69%)	29/938 (3.09%)
URINARY TRACT INFECTION † 1	14/657 (2.13%)	20/269 (7.43%)	22/938 (2.35%)
Metabolism and nutrition disorders
ANOREXIA † 1	101/657 (15.37%)	77/269 (28.62%)	240/938 (25.59%)
DEHYDRATION † 1	24/657 (3.65%)	33/269 (12.27%)	68/938 (7.25%)
HYPOKALAEMIA † 1	20/657 (3.04%)	33/269 (12.27%)	58/938 (6.18%)
DECREASED APPETITE † 1	16/657 (2.44%)	15/269 (5.58%)	27/938 (2.88%)
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY † 1	17/657 (2.59%)	21/269 (7.81%)	117/938 (12.47%)
ARTHRALGIA † 1	22/657 (3.35%)	26/269 (9.67%)	41/938 (4.37%)
BACK PAIN † 1	14/657 (2.13%)	25/269 (9.29%)	46/938 (4.90%)
PAIN IN JAW † 1	1/657 (0.15%)	0/269 (0.00%)	55/938 (5.86%)
Nervous system disorders
PARAESTHESIA † 1	16/657 (2.44%)	10/269 (3.72%)	339/938 (36.14%)
NEUROPATHY PERIPHERAL † 1	8/657 (1.22%)	12/269 (4.46%)	279/938 (29.74%)
DYSGEUSIA † 1	86/657 (13.09%)	40/269 (14.87%)	126/938 (13.43%)
HEADACHE † 1	46/657 (7.00%)	31/269 (11.52%)	103/938 (10.98%)
DIZZINESS † 1	34/657 (5.18%)	34/269 (12.64%)	99/938 (10.55%)
PERIPHERAL SENSORY NEUROPATHY † 1	4/657 (0.61%)	11/269 (4.09%)	152/938 (16.20%)
DYSAESTHESIA † 1	1/657 (0.15%)	1/269 (0.37%)	104/938 (11.09%)
LETHARGY † 1	46/657 (7.00%)	3/269 (1.12%)	52/938 (5.54%)
HYPOAESTHESIA † 1	2/657 (0.30%)	7/269 (2.60%)	59/938 (6.29%)
Psychiatric disorders
INSOMNIA † 1	49/657 (7.46%)	38/269 (14.13%)	78/938 (8.32%)
ANXIETY † 1	22/657 (3.35%)	31/269 (11.52%)	49/938 (5.22%)
DEPRESSION † 1	14/657 (2.13%)	24/269 (8.92%)	35/938 (3.73%)
Respiratory, thoracic and mediastinal disorders
COUGH † 1	15/657 (2.28%)	35/269 (13.01%)	47/938 (5.01%)
OROPHARYNGEAL PAIN † 1	39/657 (5.94%)	20/269 (7.43%)	38/938 (4.05%)
DYSPNOEA † 1	15/657 (2.28%)	16/269 (5.95%)	63/938 (6.72%)
EPISTAXIS † 1	24/657 (3.65%)	30/269 (11.15%)	40/938 (4.26%)
DYSAESTHESIA PHARYNX † 1	0/657 (0.00%)	0/269 (0.00%)	93/938 (9.91%)
RHINORRHOEA † 1	16/657 (2.44%)	20/269 (7.43%)	24/938 (2.56%)
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME † 1	56/657 (8.52%)	42/269 (15.61%)	278/938 (29.64%)
ALOPECIA † 1	159/657 (24.20%)	25/269 (9.29%)	40/938 (4.26%)
RASH † 1	65/657 (9.89%)	41/269 (15.24%)	84/938 (8.96%)
DRY SKIN † 1	41/657 (6.24%)	44/269 (16.36%)	45/938 (4.80%)
PRURITUS † 1	20/657 (3.04%)	17/269 (6.32%)	21/938 (2.24%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 12.0

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Medical Communications
• Organization: Hoffman-LaRoche
• Phone: 800-821-8590

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00069121 History of Changes
• Obsolete Identifiers: NCT00080691
• Other Study ID Numbers: NO16968
• First Submitted: September 15, 2003
• First Posted: September 18, 2003
• Results First Submitted: March 31, 2011
• Results First Posted: July 29, 2011
• Last Update Posted: August 22, 2013