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ACTIVE NOT RECRUITING
NCT03255434
PHASE2

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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.

Official title: LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy for Stage III Colon Cancer Patients Treated in Adjuvant Setting: Impact on Oxaliplatin-induced Sensitive Neurotoxicity. A Multicenter Phase II Randomized Trial (LEANOX)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2017-11-01

Completion Date

2025-07-31

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

DRUG

Oxaliplatin

Simplified FOLFOX 4 regimen: Association of Oxaliplatin (85 mg/m² ) + simplified LV5FU2 Length of a cycle : 2 days Interval between 2 cycles : 2 weeks (D1=D15) Expected number of cycles: 12

DRUG

Oxaliplatin LBM

Simplified FOLFOX 4 regimen: Association of Oxaliplatin (LBM) + simplified LV5FU2

Locations (11)

Hôpital Européen

Marseille, Bouches Du Rhône, France

Centre hospitalier régional et universitaire de Montpellier

Montpellier, Hérault, France

CHU de Nancy

Vandœuvre-lès-Nancy, Lorraine, France

Insitut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France

Hôpital Saint-Jean

Perpignan, Pyrénées-orientales, France

Centre François Baclesse

Caen, France

CHU La TIMONE

Marseille, France

Institut regional du Cancer - Val d Aurelle

Montpellier, France

AP-HP Hôpital Saint-Louis

Paris, France

Centre Eugène Marquis

Rennes, France

Centre Paul Strauss

Strasbourg, France