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
Sponsors and collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Lead sponsor
Servier
Collaborator