NCT01910610

Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer

Multi-Line Therapy Trial in Unresectable Wild-Type RAS Metastatic Colorectal Cancer. A GERCOR Randomized Open-label Phase III Study.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.

Detailed description

This is a phase III study assessing 2 mutli-line therapeutic strategies in patients with unresectable wild-type RAS metastatic colorectal cancer. All the available treatments are being used in each strategy (oxaliplatine, irinotecan, fluoropyrimidines, bevacizumab, cetuximab or panitumumab) but in a different order: STRATEGY A: FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab vs. STRATEGY B: OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	FOLFIRI-cetuximab
BIOLOGICAL	mFOLFOX6-bevacizumab
BIOLOGICAL	OPTIMOX-bevacizumab
BIOLOGICAL	irinotecan-based chemo + bevacizumab
BIOLOGICAL	Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
BIOLOGICAL	XELOX + bevacizumab

Timeline

• Start date: 2013-10-30
• Primary completion: 2023-07-13
• Completion: 2024-12-01
• First posted: 2013-07-29
• Last updated: 2024-03-12

Locations

56 sites across 3 countries: France, Ireland, Israel