NCT05462613

Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer

Induction Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin Followed by Chemotherapy in Second Line Metastatic Colorectal Cancer Carcinoma An Open-label Randomized Phase II-III Study

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 446 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	quality of life questionnaires	EORTC QLQ-C30 questionnaire (Quality of life questionnaire- Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D3L questionnaire (EuroQol-5 Dimensions, 3 levels)
PROCEDURE	Blood sample	Blood sample for plasma collection Blood sample for ctDNA (circulating tumoral DNA) collection
DRUG	Regorafenib	\- Regorafenib will be administered 3 weeks out of 4 for two months or unacceptable toxicity. * For the first cycle: regorafenib will be administered according to the "REDOS" schedule (80 mg daily for week 1, 120 mg daily for week 2 and 160 mg daily for the third week of the first cycle). * For the second cycle: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
DRUG	Metronomic chemotherapies	* Capecitabine: 625mg/m²/orally twice daily continuously during the first two months * Cyclophosphamide: 50 mg per os, daily, for two months
DRUG	Aspirin	75 mg orally and daily during two months
DRUG	Bevacizumab	5 mg/Kg every 2 weeks according to investigator practice, until disease progression or unacceptable toxicity
DRUG	FOLFIRI or FOLFOX	every 2 weeks according to investigator practice

Timeline

• Start date: 2023-05-09
• Primary completion: 2029-11-01
• Completion: 2030-11-01
• First posted: 2022-07-18
• Last updated: 2024-12-20

Locations

16 sites across 1 country: France