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NCT03255434Active, not recruitingPhase 2

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

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)

Source: ClinicalTrials.gov · Last updated 13 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (actual)
First submitted
11 Aug 2017
Start date
1 Nov 2017
Primary completion date
28 Jul 2022
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT number
NCT03255434
EU CT number
2024-515340-23-00
EudraCT number
2016-002576-27

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 160
  • From 1 Nov 2017 to the primary completion date, 28 Jul 2022
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with neurotoxic chemotherapy such as Oxaliplatin, cisplatin, taxanes, or vinca alkaloids.
  • Treatment with 1) the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g. Depakine®), gabapentin (Neurontin®); pregabalin (Lyrica®); 2) the following neurotropic agents: venlafaxine (Effexor®), desvenlafaxine (Pristiq®), milnacipran (Savella®) or duloxetine (Cymbalta®); 3) Tricyclic antidepressants (such as amitryptilline) or 4) any other agent specifically given to prevent or treat neuropathy.
  • Participation in another medication trial within 30 days prior to study entry

Other illness

  • Family history of a genetic/familial neuropathy.
  • History of other solid tumor in 3 years before the inclusion, excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.

Other

  • Pregnant or breastfeeding women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
  • Pre-existing peripheral neuropathy of any grade.
  • Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to terminate the study

Who the study is looking for

  • Age: more than 18 years old up to 75 years old including. Histologically confirmed adenocarcinoma of the colon.
  • Has undergone a curative resection for stage III colon cancer.
  • Scheduled to receive 6 months of Oxaliplatin-based adjuvant chemotherapy at a dose of 85 mg/m² of Oxaliplatin every 2 weeks (simplified FOLFOX 4 regimen).
  • The following laboratory values obtained ≤ 28 days prior to inclusion:
    • WBC ≥ 3000/mm3; ANC ≥1500/mm3; PLT ≥100,000/mm3; HgB ≥10.0g/dl; Total bilirubin ≤1.5 x upper normal limit (UNL); Serum creatinine ≤1.5 x UNL; Serum calcium ≤ 1.2 x UNL; Serum magnesium ≤ 1.2 x UNL.
  • Central venous access line present or patient scheduled to have a central line placed prior to starting chemotherapy or the treatment protocol.
  • Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • ECOG Performance Status (PS) of 0, 1 for patients until 70 years old included and ECOG PS of 0 for patients between 70 to 75 years old included.
  • Has provided informed written consent.
  • Patient willing to provide blood sample for research purposes
  • Patient affiliated to a French social security system

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier de la Cote Basque
Coordinator of this site? Confirm its status
BayonneFranceNot yet recruiting
Polyclinique Bordeaux Nord Aquitaine
Coordinator of this site? Confirm its status
Bordeaux CedexFranceNot yet recruiting
Clinique Pasteur Lanroze
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BrestFranceNot yet recruiting
Centre Francois Baclesse
Coordinator of this site? Confirm its status
Caen Cedex 5FranceNot yet recruiting
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Chambray Les ToursFranceNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
CHU De Martinique
Coordinator of this site? Confirm its status
Fort De France CedexFranceNot yet recruiting
Centre Hospitalier Departemental Vendee
Coordinator of this site? Confirm its status
La Roche Sur Yon Cedex 9FranceNot yet recruiting
Hopital Europeen Marseille
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MarseilleFranceNot yet recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceNot yet recruiting
Hôpital Saint Joseph
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MarseilleFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceNot yet recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Hopital Saint Louis
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ParisFranceNot yet recruiting
Centre Hospitalier De Perpignan
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Perpignan CedexFranceNot yet recruiting
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceNot yet recruiting
Institut Godinot
Coordinator of this site? Confirm its status
ReimsFranceNot yet recruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
Coordinator of this site? Confirm its status
Rennes CedexFranceNot yet recruiting
Groupe Hospitalier Rance Emeraude
Coordinator of this site? Confirm its status
Saint-Malo CedexFranceNot yet recruiting
Institut de Cancérologie Strasbourg Europe
Coordinator of this site? Confirm its status
StrasbourgFranceNot yet recruiting
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceNot yet recruiting
Institut De Cancerologie De Lorraine
Coordinator of this site? Confirm its status
Vandouvre Les NancyFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.