colon cancer MedDRA version: 19.1 Level: PT Classification code 10009955 Term: Colon cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Anti tumoral
Product Name: OXALIPLATIN
Pharmaceutical Form: Injection
Sponsors
Institut régional du Cancer de Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 308 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 308
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the Oxaliplatin dose adaptation/normalization based on the lean body mass index can prevent or reduce neurotoxicity associated with Oxaliplatin, for stage III colon cancer patients treated in adjuvant setting with simplified FOLFOX 4 regimen. ;Secondary Objective: To determine the impact of the Oxaliplatin dose adaptation/normalization based on the lean body mass index on: -Treatment compliance and cumulative Oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity. -Patients’ quality of life -Disease-free survival and overall survival. To describe baseline and post-treatment neurological quantitative sensory testing abnormalities in these patients. ;Primary end point(s): Percentage of patients without experiencing grade = 2 of neurotoxicity (paresthesia according to the NCI-CTCAE version 4.03) at any time during the first 6 cycles of adjuvant Oxaliplatin-based chemotherapy;Timepoint(s) of evaluation of this end point: last visit of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The cumulative Oxaliplatin doses that can be delivered without reaching the dose-limiting chronic neurotoxicity (according to the NCI-CTCAE version 4.03) and the percentage of patients discontinuing Oxaliplatin-based chemotherapy due to neurotoxicity will be evaluated. - The evolution of quality of life will be assessed with repeated measurements using the EORTC QLQ-C30 questionnaire during chemotherapy and follow-up. - The evolution of the Oxaliplatin-induced sensory neuropathy will be assessed with repeated measurements using the EORTC QLQ-CIPN20 sensory subscale during chemotherapy. - Time to onset of grade = 2 chronic cumulative neurotoxicity (according to the NCI-CTCAE version 4.03), - Duration of the chronic cumulative neurotoxicity (according to the NCI-CTCAE version 4.03) during and after adjuvant Oxaliplatin-based chemotherapy. - Incidence of other adverse events as measured according to the CTCAE version 4.03. - Disease-free survival - Overall survival - The five dimensions of the EQ-5D questionnaire;Timepoint(s) of evaluation of this end point: last visit of the last patient | — |
Countries
France
Contacts
Public ContactDr Jean Pierre BLEUSE
Institut régional du Cancer de Montpellier
Outcome results
None listed