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Stage III Colon CancerPhase 2LEANOXNCT03255434

LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

A Phase 2 study testing Oxaliplatin and Oxaliplatin LBM in people with Stage III Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 11 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stage III Colon Cancer
What is being tested?
Oxaliplatin and Oxaliplatin LBM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
11 sitesFrance
Study dates
1 Nov 2017to 31 Jul 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
  • 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.
  • Family history of a genetic/familial neuropathy.
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  • Participation in another medication trial within 30 days prior to study entry
  • 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
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Centre François Baclesse

    Caen, 14076

  • Hôpital Européen

    Marseille, Bouches Du Rhône, 13003

  • CHU La TIMONE

    Marseille, 13

  • Centre hospitalier régional et universitaire de Montpellier

    Montpellier, Hérault, 34000

  • Institut regional du Cancer - Val d Aurelle

    Montpellier, 34298

  • AP-HP Hôpital Saint-Louis

    Paris

  • Hôpital Saint-Jean

    Perpignan, Pyrénées-orientales, 66000

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Paul Strauss

    Strasbourg

  • CHU de Nancy

    Vandœuvre-lès-Nancy, Lorraine, 54511

  • Insitut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, 54519

Other trials in France

About this study

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)

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.

Read the detailed description

Adjuvant chemotherapy with fluoropyrimidines and Oxaliplatin is the current worldwide standard of care for stage III colorectal cancer (CRC). This regimen leads to significant cost, toxicity, and patient inconvenience. Oxaliplatin induces two distinct forms of neuropathy: a common acute syndrome that is transient (dysesthesia, contractures and numbness) and a dose-limiting chronic sensory neurotoxicity that is cumulative. Neurotoxicity is common; it affects 80% of patients and becomes chronic in 15-20% of cases, sometimes irreversibly. Chronic neurotoxicity can severely affect everyday life activities. To date, neuromodulators agents have failed to prevent neurotoxicity and Stop \& Go strategies, intended to decrease the cumulative dose of Oxaliplatin administrated, are more appropriate for palliative treatment of advanced CRC. Recent data support the plausibility of a shorter duration of adjuvant treatment without loss of efficacy. This hypothesis is tested in several international trials.

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. The impact of body composition on drug metabolism is however well known: i.e. anesthetics accumulate in adipose tissue and specific precautions are essential to avoid overdose. Concerning chemotherapies, the lean body mass (LBM) may be the salient feature defining drug metabolism. A theme is emerging from recent studies: in patients with breast cancer and treated with 5-FU (whose dosage was calculated from the body surface), severe depletion of the LBM is a powerful predictor of excessive toxicity. Indeed, depletion of the LBM, as precisely defined by computed tomography, is a unique predictor of clinically unacceptable toxicity. Low LBM was shown to be a significant predictor of dose-limiting toxicity (DLT) in CRC patients administered 5-FU using a conventional BSA-based dosing and DLT was concentrated in patients receiving >20 mg 5FU/kg LBM. Two cohorts of CRC patients treated with Oxaliplatin showed that overall DLTs, and specifically Oxaliplatin-due neuropathy, occurred mostly in patients who receive > 3.09 mg/Oxaliplatin/kg LBM. Although, preliminary findings are available in hepatocellular carcinoma, the area under the concentration time curve (AUC) of Sorafenib cancer therapy was doubled in patients with depleted LBM (102.4 vs. 53.7ng/mL.h), which seem of interest. 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.

Being tested
Oxaliplatin, Oxaliplatin LBM
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    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 LBMDrug

    Also called Oxaliplatin

    Simplified FOLFOX 4 regimen: Association of Oxaliplatin (LBM) + simplified LV5FU2

Study groups in NCT03255434
Study groupRoleWhat they receive
Folfox 4Active comparatorStandard FOLFOX4: Oxaliplatin and simplified LV5FU2 Dose of oxaliplatin 85mg/m²
Receives: Drug: Oxaliplatin
Folfox 4 LBMExperimentalAdapted FOLFOX4: Oxaliplatin and simplified LV5FU2 Dose of oxaliplatin allocated according to lean body mass (LBM)
Receives: Drug: Oxaliplatin LBM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of neurotoxicity associated with Oxaliplatin

    Neurotoxicity assessment

    Measured: through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start1 Nov 2017
  3. Primary completion28 Jul 2022
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03255434
Sponsor's protocol ID
ICM-URC2016/27
Acronym
LEANOX
Status last verified
Feb 2025
First submitted
11 Aug 2017
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Assenat E, Ben Abdelghani M, Gourgou S, Perrier H, Akouz FK, Desgrippes R, Galais MP, Janiszewski C, Mazard T, Rinaldi Y, Lepage C, Tetreau R, Senesse P. 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. J Clin Oncol. 2025 Aug 10;43(23):2616-2627. doi: 10.1200/JCO-24-02754. Epub 2025 Jun 20.

    PubMed 40540704

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin and Oxaliplatin LBM in people with Stage III Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of neurotoxicity associated with Oxaliplatin (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03255434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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