Trial Outcomes & Findings for Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin) (NCT NCT02612077)
NCT ID: NCT02612077
Last Updated: 2016-03-11
Results Overview
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively
Recruitment status
COMPLETED
Target enrollment
765 participants
Primary outcome timeframe
within 36 months
Results posted on
2016-03-11
Participant Flow
Participant milestones
| Measure |
Observational Chemotherapy/Bevacizumab
Observed patients receiving chemotherapy with concomitant bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
765
|
|
Overall Study
Did Not Receive Study Product
|
5
|
|
Overall Study
Safety Analysis Set
|
760
|
|
Overall Study
Efficacy Analysis Set
|
737
|
|
Overall Study
COMPLETED
|
299
|
|
Overall Study
NOT COMPLETED
|
466
|
Reasons for withdrawal
| Measure |
Observational Chemotherapy/Bevacizumab
Observed patients receiving chemotherapy with concomitant bevacizumab
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Protocol Violation
|
28
|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Death
|
377
|
|
Overall Study
Moved or Changed Medical Team
|
23
|
|
Overall Study
Enrollment in a Clinical Trial
|
1
|
|
Overall Study
Disease Progression
|
3
|
|
Overall Study
Unknown reason
|
2
|
Baseline Characteristics
Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)
Baseline characteristics by cohort
| Measure |
Observational Chemotherapy/Bevacizumab
n=737 Participants
Observed patients receiving chemotherapy with concomitant bevacizumab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
347 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
390 Participants
n=93 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
|
Gender
Female
|
293 participants
n=93 Participants
|
|
Gender
Male
|
442 participants
n=93 Participants
|
|
Region of Enrollment
France
|
737 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: within 36 monthsPopulation: Efficacy analysis set receiving bevacizumab at inclusion
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively
Outcome measures
| Measure |
Bevacizumab With 1st Line Treatment
n=521 Participants
Patients treated with bevacizumab during first line treatment of chemotherapy
|
Bevacizumab With 2nd Line Treatment
n=154 Participants
Patients treated with bevacizumab during second line treatment of chemotherapy
|
Bevacizumab With 3rd Line Treatment
n=62 Participants
Patients treated with bevacizumab during third line treatment of chemotherapy
|
|---|---|---|---|
|
Progression-free Survival
|
10.4 Months
Interval 9.6 to 11.3
|
8.5 Months
Interval 7.0 to 9.2
|
6.3 Months
Interval 4.5 to 8.9
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Efficacy analysis set receiving bevacizumab at inclusion
Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.
Outcome measures
| Measure |
Bevacizumab With 1st Line Treatment
n=521 Participants
Patients treated with bevacizumab during first line treatment of chemotherapy
|
Bevacizumab With 2nd Line Treatment
n=154 Participants
Patients treated with bevacizumab during second line treatment of chemotherapy
|
Bevacizumab With 3rd Line Treatment
n=62 Participants
Patients treated with bevacizumab during third line treatment of chemotherapy
|
|---|---|---|---|
|
Overall Survival
|
25.3 Months
Interval 21.5 to 28.6
|
19.1 Months
Interval 15.7 to 22.6
|
14.9 Months
Interval 11.6 to 20.4
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: Participants in the efficacy analysis set who filled out the questionnaire at inclusion
Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).
Outcome measures
| Measure |
Bevacizumab With 1st Line Treatment
n=521 Participants
Patients treated with bevacizumab during first line treatment of chemotherapy
|
Bevacizumab With 2nd Line Treatment
Patients treated with bevacizumab during second line treatment of chemotherapy
|
Bevacizumab With 3rd Line Treatment
Patients treated with bevacizumab during third line treatment of chemotherapy
|
|---|---|---|---|
|
Quality of Life - Global Health Status
at Inclusion (n=521)
|
67 units on a scale
Interval 50.0 to 75.0
|
—
|
—
|
|
Quality of Life - Global Health Status
at Month 6 (n=279)
|
67 units on a scale
Interval 50.0 to 83.0
|
—
|
—
|
|
Quality of Life - Global Health Status
at Month 12 (n=173)
|
67 units on a scale
Interval 50.0 to 83.0
|
—
|
—
|
|
Quality of Life - Global Health Status
at Month 18 (n=134)
|
67 units on a scale
Interval 50.0 to 83.0
|
—
|
—
|
Adverse Events
Observational Chemotherapy/Bevacizumab
Serious events: 74 serious events
Other events: 353 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Observational Chemotherapy/Bevacizumab
n=760 participants at risk
Observed patients receiving chemotherapy with concomitant bevacizumab
|
|---|---|
|
Vascular disorders
Embolism Venous
|
2.0%
15/760 • Number of events 28 • 36 months
Safety analysis population.
|
|
Vascular disorders
Embolism
|
0.79%
6/760 • Number of events 8 • 36 months
Safety analysis population.
|
|
Vascular disorders
Hypertension
|
0.53%
4/760 • Number of events 4 • 36 months
Safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
13/760 • Number of events 15 • 36 months
Safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
3/760 • Number of events 3 • 36 months
Safety analysis population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.92%
7/760 • Number of events 7 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.26%
2/760 • Number of events 2 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.26%
2/760 • Number of events 3 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Intestinal Fistula
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Necrotising Colitis
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
General disorders
Impaired healing
|
0.39%
3/760 • Number of events 3 • 36 months
Safety analysis population.
|
|
General disorders
Death
|
0.26%
2/760 • Number of events 2 • 36 months
Safety analysis population.
|
|
General disorders
General Physical Health Deterioration
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Renal and urinary disorders
Proteinuria
|
0.39%
3/760 • Number of events 3 • 36 months
Safety analysis population.
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Renal and urinary disorders
Renal Failure
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Renal and urinary disorders
Urinary Fistula
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Injury, poisoning and procedural complications
Post Procedural Fistula
|
0.26%
2/760 • Number of events 2 • 36 months
Safety analysis population.
|
|
Injury, poisoning and procedural complications
Hepatic Haematoma
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.39%
3/760 • Number of events 3 • 36 months
Safety analysis population.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Cardiac disorders
Cardiac Arrest
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Cardiac disorders
Cardiac Failure
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Nervous system disorders
Headache
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Investigations
Weight Decreased
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.13%
1/760 • Number of events 1 • 36 months
Safety analysis population.
|
Other adverse events
| Measure |
Observational Chemotherapy/Bevacizumab
n=760 participants at risk
Observed patients receiving chemotherapy with concomitant bevacizumab
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.6%
164/760 • Number of events 246 • 36 months
Safety analysis population.
|
|
Vascular disorders
Hypertension
|
15.1%
115/760 • Number of events 184 • 36 months
Safety analysis population.
|
|
Vascular disorders
Embolism venous
|
5.0%
38/760 • Number of events 49 • 36 months
Safety analysis population.
|
|
Renal and urinary disorders
Proteinuria
|
15.5%
118/760 • Number of events 215 • 36 months
Safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.2%
85/760 • Number of events 120 • 36 months
Safety analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER