Recruitment

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