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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Chemotherapy/Bevacizumab | Observed patients receiving chemotherapy with concomitant bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Chemotherapy | Other | No intervention - Observational standard practice chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
- Participating in a clinical trial assessing an anticancer treatment
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Patients with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuilly-sur-Seine | 92521 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Chemotherapy/Bevacizumab | Observed patients receiving chemotherapy with concomitant bevacizumab |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Efficacy Analysis Set. Note: 29 participants dd not continue after enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Chemotherapy/Bevacizumab | Observed patients receiving chemotherapy with concomitant bevacizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Efficacy analysis set receiving bevacizumab at inclusion | Posted | Median | 95% Confidence Interval | Months | within 36 months |
|
36 months
Safety analysis population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Chemotherapy/Bevacizumab | Observed patients receiving chemotherapy with concomitant bevacizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism Venous | Vascular disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Concomitant Bevacizumab | Drug | No intervention - Observational concomitant bevacizumab |
|
|
| 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). | Baseline, 6 and 12 months |
| Lost to Follow-up |
|
| Death |
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| Moved or Changed Medical Team |
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| Enrollment in a Clinical Trial |
|
| Disease Progression |
|
| Unknown reason |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Gender was not recorded for two patients. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Bevacizumab With 3rd Line Treatment | Patients treated with bevacizumab during third line treatment of chemotherapy |
|
|
| Secondary | 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. | Efficacy analysis set receiving bevacizumab at inclusion | Posted | Median | 95% Confidence Interval | Months | Up to 36 months |
|
|
|
| Secondary | 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). | Participants in the efficacy analysis set who filled out the questionnaire at inclusion | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 and 12 months |
|
|
|
| 74 |
| 760 |
| 353 |
| 760 |
| Embolism | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Anal Fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastric Disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Intestinal Fistula | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Necrotising Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
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| General Physical Health Deterioration | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Haemorrhage Urinary Tract | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Urinary Fistula | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Post Procedural Fistula | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Hepatic Haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Anal Haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Embolism venous | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| at Month 18 (n=134) |
|