drugset / Trial / NCT03255434

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

NCT03255434 ↗

Phase 2 Active not recruiting 160 enrolled Institut du Cancer de Montpellier - Val d'Aurelle
RandomizedParallel-groupOpen-labelTreatment

Summary

Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not adjusted to the body proportions of lean and fat (i.e. body composition) of individual patients. Patients with low muscle mass behave like patients "overdosed" with chemotherapy resulted in dose-limiting toxicities (e.g. dose reductions, treatment delays or permanent treatment discontinuation), independently of the patient's weight.

Timeline

Start
2017-11-01
Primary completion
2022-07-28
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxaliplatin Small molecule 3.09 mg/kg —
Comparator Oxaliplatin Small molecule 85 mg/m2 —