NCT03255434

Brief 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. dose reductions, treatment delays or permanent treatment discontinuation), independently of the patient's weight.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4.7 years

First QC Date

August 11, 2017

Last Update Submit

February 11, 2025

Conditions

Stage III Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation of neurotoxicity associated with Oxaliplatin

    Neurotoxicity assessment

    through study completion, an average of 5 years

Study Arms (2)

Folfox 4

ACTIVE COMPARATOR

Standard FOLFOX4: Oxaliplatin and simplified LV5FU2 Dose of oxaliplatin 85mg/m²

Drug: Oxaliplatin

Folfox 4 LBM

EXPERIMENTAL

Adapted FOLFOX4: Oxaliplatin and simplified LV5FU2 Dose of oxaliplatin allocated according to lean body mass (LBM)

Drug: Oxaliplatin LBM

Interventions

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

Folfox 4
Oxaliplatin LBMDRUG

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

Also known as: Oxaliplatin
Folfox 4 LBM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Européen

Marseille, Bouches Du Rhône, 13003, France

Location

Centre hospitalier régional et universitaire de Montpellier

Montpellier, Hérault, 34000, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

Insitut de Cancérologie de Lorraine

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

Location

Hôpital Saint-Jean

Perpignan, Pyrénées-orientales, 66000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CHU La TIMONE

Marseille, 13, France

Location

Institut regional du Cancer - Val d Aurelle

Montpellier, 34298, France

Location

AP-HP Hôpital Saint-Louis

Paris, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Related Publications (1)

  • 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.

    PMID: 40540704DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • marc YCHOU

    Institut régional du Cancer de Montpellier

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 21, 2017

Study Start

November 1, 2017

Primary Completion

July 28, 2022

Study Completion

July 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)