Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Multicenter, international, comparative, randomized, open-label, phase II study conducted in two parallel groups. The study population will consist of male and female patients aged ?18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based ...
Multicenter, international, comparative, randomized, open-label, phase II study conducted in two parallel groups. The study population will consist of male and female patients aged ?18 years old with metastatic colorectal cancer after failure of fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapies, as well as epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) inhibitors in patients eligible for these treatments. Patients will be randomized according to a 1:1 ratio to treatment arms A and B. Arm A: regorafenib until disease progression or unacceptable toxicity occurs, followed by trifluridine/tipiracil until disease progression or unacceptable toxicity occurs. Arm B: trifluridine/tipiracil until disease progression or unacceptable toxicity occurs, followed by regorafenib until disease progression or unacceptable toxicity occurs.
Tracking Information
- NCT #
- NCT04450836
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michel MD DUCREUX, Pr Gustave Roussy, Cancer Campus, Grand Paris