Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Antipyretics

Anti-Inflammatory Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Capecitabine

Cyclophosphamide

Bevacizumab

Aspirin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Regorafenib + metronomic Capecitabine + metronomic Cyclophosphamide + low-dose Aspirin followed by second line of chemotherapy (Bevacizumab + FOLFOX or FOLFIRI)

Second line of chemotherapy (Bevacizumab + FOLFOX or FOLFIRI)

EORTC QLQ-C30 questionnaire (Quality of life questionnaire- Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D3L questionnaire (EuroQol-5 Dimensions, 3 levels)

quality of life questionnaires

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

Blood sample

- 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.

Regorafenib

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

Metronomic chemotherapies

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

every 2 weeks according to investigator practice

FOLFIRI or FOLFOX

Angélique VIENOT, MD, PhD

Christophe BORG, MD, PhD

Anéglique VIENOT, MD, PhD

Christophe TOURNIGAND

François GHIRINGHELLI, Pr

Christelle DE LA FOUCHARDIERE, Pr

Jérôme DESRAME, Dr

Christophe BORG, Pr

Stéphanie HUSSON-WETZEL, Dr

Claire Gallois, Dr

Jean-Baptiste BACHET

Romain COHEN

Emilie SOULARUE, Dr

Olivier BOUCHE, Dr

Asmahane BENMAZIANE TEILLET

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

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

the best response rate evaluated with RECIST v1.1 criteria per an independent radiologist committee during the treatment period defined as the number of with complete response (CR) or partial response (PR) as best response divided by the total number of patients evaluable. Patients for whom best overall tumor response is not CR or PR will be considered non-responders.

Overall survival is defined as the time from the randomization to death from any cause.

Centre Hospitalier Universitaire de Besancon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer	NCT05462613	Metastatic Colo...	quality of life... Blood sample Regorafenib Metronomic chem... Aspirin Bevacizumab FOLFIRI or FOLF...	18 Years -	Centre Hospitalier Universitaire de Besancon
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer	NCT05462613	Metastatic Colo...	quality of life... Blood sample Regorafenib Metronomic chem... Aspirin Bevacizumab FOLFIRI or FOLF...	18 Years -	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for metronomic chemotherapies