BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT07071844
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Trifluridine/tipiracil — DRUG
    35 mg/m², orally
  • Bevacizumab — DRUG
    5 mg/kg, intravenous route

Study Details

This study was design to: * To assess the impact of a biweekly (experimental arm) compared to a conventional administration (control arm) on the rate of grade 3-4 neutropenia in metastatic colorectal cancer (mCRC) patients treated with trifluridine/tipiracil plus bevacizumab, and * To identify predictive clinical and biological factors for grade 3-4 neutropenia in this patient population.

Key Dates

First listed
Jul 17, 2025
Start date
Sep 30, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Arm A (experimental) - Trifluridine/tipiracil plus bevacizumab biweekly administration
    Trifluridine/tipiracil: 35 mg/m², twice daily (BId) orally, on days 1-5 and days 15-19; 1 cycle every 28 days. \+ Bevacizumab: 5 mg/kg intravenously (IV) on day 1 and day 15; 1 cycle every 28 days.
  • Active Comparator: Arm B (control) - Trifluridine/tipiracil plus bevacizumab conventional administration
    Trifluridine/tipiracil: 35 mg/m² Bid orally on days 1-5 and days 8-12; 1 cycle every 28 days. \+ Bevacizumab: 5 mg/kg IV on day 1 and day 15; 1 cycle every 28 days.

Primary Outcome Measure

The occurrence of at least one grade 3-4 neutropenia [ Time Frame: From randomization up to 14 days after the end of treatment ]

Central Contacts

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