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

Sponsor
Centre Hospitalier Universitaire de Besancon
Study ID
NCT05462613
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • quality of life questionnaires — OTHER
    EORTC QLQ-C30 questionnaire (Quality of life questionnaire- Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D3L questionnaire (EuroQol-5 Dimensions, 3 levels)
  • Blood sample — PROCEDURE
    Blood sample for plasma collection Blood sample for ctDNA (circulating tumoral DNA) collection
  • Regorafenib — DRUG
    \- 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.
  • Metronomic chemotherapies — DRUG
    * Capecitabine: 625mg/m²/orally twice daily continuously during the first two months * Cyclophosphamide: 50 mg per os, daily, for two months
  • Aspirin — DRUG
    75 mg orally and daily during two months
  • Bevacizumab — DRUG
    5 mg/Kg every 2 weeks according to investigator practice, until disease progression or unacceptable toxicity
  • FOLFIRI or FOLFOX — DRUG
    every 2 weeks according to investigator practice

Study Details

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

Key Dates

First listed
Jul 18, 2022
Start date
May 9, 2023
Status verified
Nov 2024
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
446 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Regorafenib + metronomic Capecitabine + metronomic Cyclophosphamide + low-dose Aspirin followed by second line of chemotherapy (Bevacizumab + FOLFOX or FOLFIRI)
  • Active Comparator: Control
    Second line of chemotherapy (Bevacizumab + FOLFOX or FOLFIRI)

Primary Outcome Measure

best objective response during treatment period (phase II) [ Time Frame: during treatment period (from first treatment administration and disease progression, an average of 14 months ]

Central Contacts

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