An observational study in Metastatic Colorectal Cancer, sponsored by Hoffmann-La Roche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Hoffmann-La Roche · Observational
This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 765 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
Exclusion Criteria:
Observed patients receiving chemotherapy with concomitant bevacizumab
Other: Observational Chemotherapy · Drug: Concomitant Bevacizumab
No intervention - Observational standard practice chemotherapy
No intervention - Observational concomitant bevacizumab
Also known as: Avastin
Progression-free Survival
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
Time frame: within 36 months
Overall Survival
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.
Time frame: Up to 36 months
Quality of Life - Global Health Status
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).
Time frame: Baseline, 6 and 12 months
| Milestone | Observational Chemotherapy/Bevacizumab |
|---|---|
| Started | 765 |
| Did not receive study product | 5 |
| Safety analysis set | 760 |
| Efficacy analysis set | 737 |
| Completed | 299 |
| Not completed | 466 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Protocol violation | 28 |
| Withdrew: Lost to follow-up | 20 |
| Withdrew: Death | 377 |
| Withdrew: Moved or changed medical team | 23 |
| Withdrew: Enrollment in a clinical trial | 1 |
| Withdrew: Disease progression | 3 |
| Withdrew: Unknown reason | 2 |
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
| Months | Bevacizumab With 1st Line Treatment | Bevacizumab With 2nd Line Treatment | Bevacizumab With 3rd Line Treatment |
|---|---|---|---|
| Progression-free Survival | 10.4 (9.6 to 11.3) | 8.5 (7.0 to 9.2) | 6.3 (4.5 to 8.9) |
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.
| Months | Bevacizumab With 1st Line Treatment | Bevacizumab With 2nd Line Treatment | Bevacizumab With 3rd Line Treatment |
|---|---|---|---|
| Overall Survival | 25.3 (21.5 to 28.6) | 19.1 (15.7 to 22.6) | 14.9 (11.6 to 20.4) |
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).
| units on a scale | Observational Chemotherapy/Bevacizumab |
|---|---|
| at Inclusion (n=521) | 67 (50 to 75) |
| at Month 6 (n=279) | 67 (50 to 83) |
| at Month 12 (n=173) | 67 (50 to 83) |
| at Month 18 (n=134) | 67 (50 to 83) |
Collected over 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observational Chemotherapy/Bevacizumab | — | 74/760 (9.7%) | 353/760 (46.4%) |
| Event | Observational Chemotherapy/Bevacizumab |
|---|---|
| Embolism VenousVascular disorders | 15/760 |
| NeutropeniaBlood and lymphatic system disorders | 13/760 |
| Gastrointestinal perforationGastrointestinal disorders | 7/760 |
| EmbolismVascular disorders | 6/760 |
| HypertensionVascular disorders | 4/760 |
| AnaemiaBlood and lymphatic system disorders | 3/760 |
| Impaired healingGeneral disorders | 3/760 |
| ProteinuriaRenal and urinary disorders | 3/760 |
| Female Genital Tract FistulaReproductive system and breast disorders | 3/760 |
| Anal FistulaGastrointestinal disorders | 2/760 |
| Event | Observational Chemotherapy/Bevacizumab |
|---|---|
| EpistaxisRespiratory, thoracic and mediastinal disorders | 164/760 |
| ProteinuriaRenal and urinary disorders | 118/760 |
| HypertensionVascular disorders | 115/760 |
| NeutropeniaBlood and lymphatic system disorders | 85/760 |
| Embolism venousVascular disorders | 38/760 |
Efficacy Analysis Set. Note: 29 participants dd not continue after enrollment.
| Age, Categorical(Participants) | Observational Chemotherapy/Bevacizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 347 |
| >=65 years | 390 |
| Age, Continuous(years) | Observational Chemotherapy/Bevacizumab |
|---|---|
| Mean | 64.5 ± 10.9 |
| Gender(participants) | Observational Chemotherapy/Bevacizumab |
|---|---|
| Female | 293 |
| Male | 442 |
| Region of Enrollment(participants) | Observational Chemotherapy/Bevacizumab |
|---|---|
| France | 737 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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