RecruitingPhase 2Phase 3NCT05462613

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

446 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a metronomic (low-dose, continuous) chemotherapy approach — combined with regorafenib and aspirin — in people with metastatic colorectal cancer that has progressed after first-line treatment. The idea is to maintain disease control with a gentler regimen before escalating to stronger chemotherapy, potentially reducing toxicity. **You may be eligible if...** - You are 18 or older with confirmed metastatic colorectal cancer - Your cancer has progressed after exactly one standard first-line chemotherapy regimen (e.g., FOLFOX, FOLFIRI, or FOLFIRINOX) - You are well enough to receive further treatment and your organ function is adequate - You have not had surgery that would make aspirin or anti-clotting drugs unsafe **You may NOT be eligible if...** - You have had more than one prior chemotherapy line for metastatic disease - You have a bleeding disorder or conditions making aspirin or regorafenib unsafe - You have severe heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERquality 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)

PROCEDUREBlood sample

Blood sample for plasma collection Blood sample for ctDNA (circulating tumoral DNA) collection

DRUGRegorafenib

\- 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.

DRUGMetronomic chemotherapies

* Capecitabine: 625mg/m²/orally twice daily continuously during the first two months * Cyclophosphamide: 50 mg per os, daily, for two months

DRUGAspirin

75 mg orally and daily during two months

DRUGBevacizumab

5 mg/Kg every 2 weeks according to investigator practice, until disease progression or unacceptable toxicity

DRUGFOLFIRI or FOLFOX

every 2 weeks according to investigator practice

Locations(16)

CHU de Besançon

Besançon, France

CHU Estain

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

Centre Georges François Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Hôpital Privé Jean Mermoz

Lyon, France

Hôpital Nord Franche Comté

Montbéliard, France

CHU Montpellier

Montpellier, France

Groupe hospitalier de la région de Mulhouse et Sud Alsace

Mulhouse, France

Centre Antoine Lacassagne

Nice, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital la Pitié-Salpétrière

Paris, France

Hôpital Saint antoine

Paris, France

Institut Mutualiste Montsouris

Paris, France

CHU de Reims - Hôpital Robert Debré

Reims, France

Hôpital FOCH

Suresnes, France

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NCT05462613

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