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
- Diseases
- Colorectal cancer
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Not yet recruiting |
| Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Not yet recruiting |
| Clinique Pasteur Lanroze Coordinator of this site? Confirm its status | Brest | France | Not yet recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| CHU De Martinique Coordinator of this site? Confirm its status | Fort De France Cedex | France | Not yet recruiting |
| Centre Hospitalier Departemental Vendee Coordinator of this site? Confirm its status | La Roche Sur Yon Cedex 9 | France | Not yet recruiting |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier De Perpignan Coordinator of this site? Confirm its status | Perpignan Cedex | France | Not yet recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Not yet recruiting |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Not yet recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Not yet recruiting |
| Groupe Hospitalier Rance Emeraude Coordinator of this site? Confirm its status | Saint-Malo Cedex | France | Not yet recruiting |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Not yet recruiting |
| Institut De Cancerologie De Lorraine Coordinator of this site? Confirm its status | Vandouvre Les Nancy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.