Evidence map›Paper›PMID 40540704›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Impact of Lean Body Mass-Based Oxaliplatin Dose Calculation on Neurotoxicity in Adjuvant Treatment of Stage III Colon Cancer: Results of the Phase II Randomized LEANOX Trial.

Eric Assenat, Meher Ben Abdelghani, Sophie Gourgou, Hervé Perrier, Faiza Khemissa Akouz, Romain Desgrippes, Marie-Pierre Galais, Chloé Janiszewski, Thibault Mazard, Yves Rinaldi and 3 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03255434 (LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy for Stage III Colon Cancer Patients Treated in Adjuvant Setting), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03255434 phase2active not recruitingnot on this map

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)

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2017 to 2025Enrolled160ConditionsStage III Colon CancerArmsOxaliplatin, Oxaliplatin LBM
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Nutritional Risk and Unmet Nutritional Need in Ambulatory Patients Undergoing Systemic Anti-Cancer Therapies.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2026
    Observational
  4. Article
  5. Network temperature and stability of symptom clusters in colorectal cancer patients undergoing adjuvant chemotherapy: a prospective longitudinal study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Eric AssenatDepartment of Medical Oncology, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.ORCID 0000-0002-8958-2793
Meher Ben AbdelghaniMedical Oncology Department, ICANS, Strasbourg, France.
Sophie GourgouBiometric Unit, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.
Hervé PerrierOncology Department, Saint Joseph Hospital, Marseille, France.
Faiza Khemissa AkouzDepartment of Gastroenterology and GI Oncology, CH Saint-Jean, Perpignan, France.
Romain DesgrippesDepartment of Hepatogastroenterology and Digestive Oncology, CH Saint-Malo, Saint-Malo, France.
Marie-Pierre GalaisDepartment of Digestive Oncology, Baclesse Center, Caen, France.
Chloé JaniszewskiClinical Research and Innovation Department, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.ORCID 0000-0002-3968-1021
Thibault MazardDepartment of Medical Oncology, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.ORCID 0000-0002-5644-9603
Yves RinaldiHepatogastroenterology Department, European Hospital of Marseille, Marseille, France.
Côme LepageDepartment of Hepato-Gastroenterology & Digestive Oncology, INSERM EPICAD CTM 1231, University Hospital of Dijon Bourgogne, Dijon, France.ORCID 0000-0001-9211-4707
Raphael TetreauDepartment of Radiology, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.
Pierre SenesseDepartment of Clinical Nutrition and Gastroenterology, Montpellier Cancer Institute (ICM), Montpellier University, Montpellier, France.ORCID 0000-0003-3542-2898

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOxaliplatin-based adjuvant chemotherapy is used for stage III colon cancer, but may induce disabling neurotoxicity. We previously showed that the incidence of oxaliplatin-induced peripheral neurotoxicity (OIPN) is higher for oxaliplatin doses >3.09 mg per kg of lean body mass (LBM). This proof-of-concept, multicenter, randomized trial assessed whether LBM-based oxaliplatin dose adjustment reduces OIPN (ClinicalTrials.gov identifier: NCT03255434).

methodsAmong the patients with resected stage III colon cancer eligible for adjuvant leucovorin, fluorouracil, and oxaliplatin chemotherapy, those without LBM reduction received body surface area (BSA)-based oxaliplatin doses (85 mg/m

resultsIn all, 33, 64, and 63 patients were enrolled in arms 1, 2, and 3, respectively (median age, 63 years; 52.5% of men; 89.3% Eastern Cooperative Oncology Group 0; 57.5% pT3; 60.6% pN1). The primary end point was achieved by 67.2% of patients in arm 3 versus 42.1% in arm 2 (

conclusionIn adjuvant settings for stage III colon cancer, using an LBM-based oxaliplatin dose significantly reduces OIPN and improves quality of life without affecting relapse-free survival and OS.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColonic NeoplasmsNeurotoxicity SyndromesOrganoplatinum CompoundsPeripheral Nervous System DiseasesAdultAgedChemotherapy, AdjuvantFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasm StagingOxaliplatinFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID40540704
PMCPMC12316125

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.