LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy (NCT04166604) | Clinical Trial Compass
Active — Not RecruitingPhase 2
LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy
France176 participantsStarted 2020-05-20
Plain-language summary
Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent,
✓. Patients willing and able to comply with protocol requirements,
✓. Previous chemotherapy regimens with each of the following agents: fluoropyrimidine, oxaliplatin, irinotecan, anti-vascular endothelial growth factor (VEGF) therapy (bevacizumab, aflibercept), and anti-epidermal growth factor receptor (EGFR) therapy (cetuximab or panitumumab for tumors with wild-type RAS and/or BRAF wild type),
✓. At least one measurable or evaluable lesion as assessed by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to RECIST v1.1,
✓. Age ≥ 18 years,
Exclusion criteria
✕. 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 the first dose of treatment),
✕. Local or locally advanced disease (stage I to III),
✕. Treatment with warfarin,
✕. Uncontrolled hypercalcemia,
What they're measuring
1
Rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months or at progression or death or stop of treatment for another cause than neutropenia if observed in 6 months.
Timeframe: At 6 months
Trial details
NCT IDNCT04166604
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group