drugset / Trial / NCT03255434
LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxaliplatin | Small molecule | 3.09 mg/kg | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |