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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

About this trial

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.

Eligibility criteria

Qualifiers

Signed and dated informed consent,

Patients willing and able to comply with protocol requirements,

Age ≥ 18 years,

ECOG PS 0-1,

Disqualifiers

ECOG PS 2,

Medical history or evidence of CNS metastasis upon physical examination, unless adequately treated (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, patients are stable without evidence of progression for at least 28 days prior to inclusion),

Local or locally advanced disease (stage I to III),

Concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),

Trial design

Treatments tested in this trial

  • Trifluridine/tipiracil
  • Bevacizumab

Treatment groups

162 Participants
are divided into 2 treatment groups

Sponsors and collaborators