Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Study ID
- NCT01910610
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Colorectal Cancer Metastatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FOLFIRI-cetuximab — BIOLOGICAL
- mFOLFOX6-bevacizumab — BIOLOGICAL
- OPTIMOX-bevacizumab — BIOLOGICAL
- irinotecan-based chemo + bevacizumab — BIOLOGICAL
- Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab) — BIOLOGICAL
- XELOX + bevacizumab — BIOLOGICAL
Study Details
STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.
Key Dates
- Start date
- Oct 30, 2013
- Status verified
- Mar 2024
- Primary completion
- Jul 13, 2023
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 464 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: STRATEGY AFOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
- Experimental: STRATEGY BOPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan
Primary Outcome Measure
Duration of Disease Control (DDC) [ Time Frame: From baseline until end of strategy; up to 80 months after the beginning of the study ]
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