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LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
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
Conditions
Interventions
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
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