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

NCT05462613 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2024-12-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2029-11-30
Completion
2030-11-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462613 on ClinicalTrials.gov