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Trial record 50 of 722 for:    colon cancer AND 5-FU

An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319877
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Colorectal Cancer
Enrollment 609
Recruitment Details  
Pre-assignment Details Three enrolled participants received third-line therapy and were not included in the evaluable population.
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy. Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Period Title: Overall Study
Started 453 153
Completed 345 108
Not Completed 108 45
Reason Not Completed
Lost to Follow-up             100             37
Physician Decision             2             0
Disease Progression             2             2
Withdrawal by Subject             0             1
Reason Not Specified             4             5
Arm/Group Title First Line Treatment Second Line Treatment Total
Hide Arm/Group Description Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy. Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy. Total of all reporting groups
Overall Number of Baseline Participants 453 153 606
Hide Baseline Analysis Population Description
Safety analysis set and efficacy analysis set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 453 participants 153 participants 606 participants
55.7  (11.9) 54.5  (11.9) 55.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 453 participants 153 participants 606 participants
Female
183
  40.4%
53
  34.6%
236
  38.9%
Male
270
  59.6%
100
  65.4%
370
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 453 participants 153 participants 606 participants
453 153 606
1.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Unit of Measure: percentage of participants
76.4 68.0
2.Primary Outcome
Title Percentage of Participants With Serious Adverse Events
Hide Description A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Unit of Measure: percentage of participants
4.9 4.6
3.Primary Outcome
Title Percentage of Participants With Adverse Events of Special Interest
Hide Description [Not Specified]
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Unit of Measure: percentage of participants
9.1 5.9
4.Primary Outcome
Title Percentage of Participants With Bevacizumab-Related Adverse Events
Hide Description [Not Specified]
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Unit of Measure: percentage of participants
54.5 45.8
5.Primary Outcome
Title Percentage of Participants With Bevacizumab-related Serious Adverse Events
Hide Description [Not Specified]
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Unit of Measure: percentage of participants
3.1 2.0
6.Secondary Outcome
Title Percentage of Participants Achieving an Overall Response
Hide Description Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.0
(17.3 to 25.0)
10.5
(6.1 to 16.4)
7.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(8.2 to 10.0)
8.1
(6.0 to 11.0)
8.Secondary Outcome
Title One-year Progression-free Survival Rate
Hide Description One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.2
(26.8 to 41.7)
29.9
(18.6 to 42.1)
9.Secondary Outcome
Title One-year Survival Rate
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.7
(62.7 to 74.0)
69.1
(59.1 to 77.2)
10.Secondary Outcome
Title Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
Hide Description Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known KRAS status were evaluated.
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Wild-type
18.6
(9.7 to 30.9)
10.3
(2.2 to 27.4)
Mutant-type
10.7
(5.0 to 19.4)
4.8
(0.1 to 23.8)
11.Secondary Outcome
Title One-year Progression-free Survival Rate Per KRAS Subgroup
Hide Description One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known KRAS status were evaluated.
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Wild-type
45.2
(22.6 to 65.4)
31.3
(8.8 to 57.3)
Mutant-type
19.5
(7.5 to 35.6)
0
(0 to 0)
12.Secondary Outcome
Title One-year Survival Rate by the KRAS Subgroup
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known KRAS status were evaluated
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Wild-type
81.0
(64.7 to 90.3)
69.1
(43.4 to 84.9)
Mutant-type
57.9
(42.7 to 70.4)
33.9
(8.4 to 62.2)
13.Secondary Outcome
Title Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
Hide Description Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known prior chemotherapy regimens were evaluated
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
FOLFOX
25.7
(19.4 to 32.9)
15.2
(5.1 to 31.9)
IFL
18.5
(12.9 to 25.4)
10.9
(5.3 to 19.1)
XELIRI
45.5
(16.7 to 76.6)
14.3
(0.4 to 57.9)
XELOX
32.1
(19.9 to 46.3)
0
(0 to 41.0)
Others
5.8
(1.2 to 15.9)
7.1
(0.2 to 33.9)
14.Secondary Outcome
Title One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
Hide Description One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known prior chemotherapy regimens were evaluated.
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
FOLFOX
38.9
(28.1 to 49.5)
38.1
(16.0 to 60.1)
IFL
29.1
(16.9 to 42.4)
32.2
(16.5 to 49.1)
XELIRI
13.3
(0.8 to 43.3)
20.0
(0.8 to 58.2)
XELOX
44.9
(17.1 to 69.6)
20.8
(0.9 to 59.5)
Others
19.5
(3.6 to 45.0)
16.7
(0.8 to 51.7)
15.Secondary Outcome
Title One-year Survival Rate by the Chemotherapy Regimen Subgroup
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with known prior chemotherapy regimens were evaluated
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 453 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
FOLFOX
66.6
(56.8 to 74.7)
71.6
(47.0 to 86.2)
IFL
70.8
(60.6 to 78.8)
71.4
(58.2 to 81.0)
XELIRI
66.7
(27.2 to 88.1)
20.8
(0.9 to 59.5)
XELOX
75.2
(56.1 to 86.9)
0
(0 to 0)
Others
64.7
(38.4 to 82.0)
60.0
(25.3 to 82.7)
16.Secondary Outcome
Title Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Hide Description Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.
Time Frame Up to 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants.
Arm/Group Title First Line Treatment Second Line Treatment
Hide Arm/Group Description:
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
Overall Number of Participants Analyzed 248 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=248,67) 63.68  (18.020) 65.67  (14.103)
Visit 2 (n=159,44) 62.89  (15.875) 64.96  (17.105)
Visit 3 (n=80,21) 59.79  (18.073) 56.35  (19.168)
Visit 4 (n=50,12) 54.83  (22.718) 61.11  (14.360)
Visit 5 (n=26,9) 57.05  (15.758) 62.96  (16.724)
Visit 6 (n=15,5) 57.22  (14.389) 73.33  (16.030)
Visit 7 (n=11,4) 56.82  (16.168) 72.92  (15.773)
Visit 8 (n=7,3) 60.72  (14.205) 66.67  (8.335)
Visit 9 (n=4,1) 45.83  (15.960) 66.67 [1]   (NA)
Visit 10 (n=1,0) 50.00 [1]   (NA) NA [2]   (NA)
[1]
Not calculable, due to single data point.
[2]
Not calculable, due to no participants for this data point.
Time Frame Up to 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First and Second Line Treatment
Hide Arm/Group Description The participants from the first line and second line treatments were combined for the adverse event analysis.
All-Cause Mortality
First and Second Line Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
First and Second Line Treatment
Affected / at Risk (%)
Total   29/606 (4.79%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/606 (0.17%) 
Bone marrow failure  1  1/606 (0.17%) 
Cardiac disorders   
Myocardial infarction  1  2/606 (0.33%) 
Angina pectoris  1  1/606 (0.17%) 
Gastrointestinal disorders   
Enteritis  1  2/606 (0.33%) 
Intestinal obstruction  1  2/606 (0.33%) 
Intestinal perforation  1  2/606 (0.33%) 
Gastritis  1  1/606 (0.17%) 
Gastrointestinal hemorrhage  1  1/606 (0.17%) 
Gastrointestinal perforation  1  1/606 (0.17%) 
Mouth ulceration  1  1/606 (0.17%) 
Large intestinal obstruction  1  1/606 (0.17%) 
Enterovesical fistula  1  1/606 (0.17%) 
General disorders   
Pyrexia  1  2/606 (0.33%) 
Infections and infestations   
Infection  1  2/606 (0.33%) 
Bacteremia  1  1/606 (0.17%) 
Peritonitis  1  1/606 (0.17%) 
Urinary tract infection  1  1/606 (0.17%) 
Injury, poisoning and procedural complications   
Urinary tract stoma complication  1  1/606 (0.17%) 
Investigations   
Neutrophil count decreased  1  2/606 (0.33%) 
Nervous system disorders   
Hypoxic-ischaemic encephalopathy  1  1/606 (0.17%) 
Renal and urinary disorders   
Ureteric fistula  1  1/606 (0.17%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/606 (0.17%) 
Vascular disorders   
Deep vein thrombosis  1  4/606 (0.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
First and Second Line Treatment
Affected / at Risk (%)
Total   450/606 (74.26%) 
Blood and lymphatic system disorders   
Bone marrow failure  1  73/606 (12.05%) 
Gastrointestinal disorders   
Nausea  1  108/606 (17.82%) 
Vomiting  1  93/606 (15.35%) 
Diarrhea  1  65/606 (10.73%) 
Constipation  1  31/606 (5.12%) 
General disorders   
Pyrexia  1  58/606 (9.57%) 
Fatigue  1  52/606 (8.58%) 
Investigations   
White blood cell count decreased  1  130/606 (21.45%) 
Neutrophil count decreased  1  100/606 (16.50%) 
Platelet count decreased  1  39/606 (6.44%) 
Alanine aminotransferase increased  1  37/606 (6.11%) 
Aspartate aminotransferase increased  1  36/606 (5.94%) 
Metabolism and nutrition disorders   
Decreased appetite  1  50/606 (8.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01319877     History of Changes
Other Study ID Numbers: ML25391
First Submitted: March 18, 2011
First Posted: March 22, 2011
Results First Submitted: April 21, 2016
Results First Posted: September 7, 2016
Last Update Posted: September 7, 2016