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LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

NCT04166604 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trifluridine/Tipiracil

After morning and evening meal Days 1 through 5: 35mg/m2 (twice daily) Days 6 through 7: recovery Days 8 through 12: 35mg/m2 (twice daily) Day 13 through 28: recovery

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Jean Baptiste BACHET, MD · Hôpital Pitié Salpêtrière

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2023-11-10
Completion
2025-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166604 on ClinicalTrials.gov