LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy

Korábbi kezelés

• 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

Más betegség

• 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.

Egyéb

• 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

• 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