Status:
ACTIVE_NOT_RECRUITING
LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Stage III Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03255434
Start Date
November 1 2017
End Date
July 31 2025
Last Update
February 13 2025
Active Locations (11)
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1
Hôpital Européen
Marseille, Bouches Du Rhône, France, 13003
2
Centre hospitalier régional et universitaire de Montpellier
Montpellier, Hérault, France, 34000
3
CHU de Nancy
Vandœuvre-lès-Nancy, Lorraine, France, 54511
4
Insitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France, 54519