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LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

Study acronym: LEANOX
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion date: Dec 2024 to Jul 31, 2025v8
  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date changed from estimate of Apr 30, 2022 to Jul 28, 2022v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 308 to confirmed 160
    • Primary completion date: Dec 2021 to Apr 30, 2022
    • Site details revised at 11 of 11 sites
    v5
  5. Study sites: 1 to 11v4
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  1. Primary completion date: Mar 2019 to Dec 2021
    • Start date: Mar 1, 2017 to Nov 1, 2017
    • Study completion date: Apr 2022 to Dec 2024
    v3
  2. Interventions: Oxaliplatin (Drug) to Oxaliplatin (Drug), Oxaliplatin LBM (Drug)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03255434
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)		 Stage III Colon Cancer
Related terms Colonic Neoplasms
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov