An Expanded Access Program of Avastin in Patients With Metastatic Cancer of Colon or Rectum - Brazilian Extension Study
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Expanded Access Program of Avastin in Patients With Metastatic Cancer of Colon or Rectum - Brazilian Extension Study
Inclusion Criteria:
- Previously untreated metastatic colon or rectal cancer;
- Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.
Exclusion Criteria:
- Prior chemotherapy for metastatic colon or rectal cancer;
- Planned radiotherapy for underlying disease;
- central nervous system metastases;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
before study start.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Serious and specific adverse events
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Brazil: National Health Surveillance Agency
Study ID:
ML20552
NCT ID:
NCT01169558
Start Date:
May 2006
Completion Date:
December 2009
Related Keywords:
- Colorectal Cancer
- Colonic Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
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