Adjuvant treatment in stage III adenocarcinoma of the colon fully resected for patient of 70 years and over
Conditions
Interventions
Trade Name: Fluorouracil Accord Healthcare 50 mg/ml, solution pour injection ou perfusion
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACIL
Other descriptive name: FLUOROURA
Sponsors
Fédération Francophone de Cancérologie Digestive (FFCD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 70 years - Patient considered enough fit to receive chemotherapy according to the multidiciplinary committee - Lee score completed and faxed to the CRGA - Stage III colonic adenocarcinoma or upper rectum - R0 resection of the primary tumor - Adjuvant chemotherapy can start within 12 weeks after surgery - No prior chemotherapy for colon cancer - Self-administered (patient) geriatric questionnaire completed and faxed to the CRGA - Team geriatric questionnaire completed and faxed to the CRGA - Effective contraception for male patients during treatment and for at least 6 months after discontinuation of oxaliplatin - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Other progressive malignant tumor (cancer not stabilized for less than 2 years ) - Rectal cancer (located within 15 cm from the anal verge by endoscopy or below the peritoneal reflection ) - PNN < 2 000/mm3 for group 1 and PNN <1 500/mm3 for group 2, platelets <100000/mm3 or hemoglobin <9 g / dL - Neuropathy for patients in group 1 - Known deficit of dihydropyrimidine dehydrogenase (DPD) - Patients with severe hepatic impairment - Any contra-indications for the drugs used in the study - Geographical, sociological or psychological conditions that would not permit the patient to complete the medical study follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study population will be dichotomized into two groups (group 1 and group 2) according to the investigator's choice, after a multidisciplinary assessment involving geriatric settings. The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients of 70 years or more, after resection of the stage III colon cancer. Group 1 (fit to receive a bi-chemotherapy): we expect an improvement of 7% of the RFS in the arm with oxaliplatin compared to 5FU or capecitabin arm Group 2 (unfit to receive bi-chemotherapy): we expect an improvement of 15% of the RFS in the arm with chemotherapy (5-FU or capecitabin) compared with observation alone arm.;Secondary Objective: The secondary objectives are: - Dose intensity - Safety (NCI CTC 4.0) - Time to recurrence, - Overall survival, - Time to degradation of autonomy, - Time to deterioration of the quality of life.;Primary end point(s): The main objective is to compare recurrence-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of elderly patients, after resection of stage III colon cancer. Group 1 (fit to receive a bi-chemotherapy): we expect a 7% improvement in recurrence-free survival in the arm with oxaliplatin compared to 5FU or capecitabin arm. Group 2 (unfit to receive bi-chemotherapy): we expect a 15% improvement in recurrence-free survival in the chemotherapy arm compared with observation alone arm.;Timepoint(s) of evaluation of this end point: The recurrence-free survival (RFS) is estimated at 3 years after the last patient is randomised | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are to compare for the two treatment strategies for each group: - The dose intensity - Safety (NCI CTC 4.0) - Time to recurrence - Overall survival - The time to deterioration of autonomy - The time to deterioration in quality of life Exploratory analyses: reserach of geriatric prognostic factors for the primary endpoint.;Timepoint(s) of evaluation of this end point: All these endoints will be evaluated at 3 years after the last patient is randomised. Overall survival can be re-evaluated later. | — |
Countries
Belgium, France
Contacts
Public ContactMicheline Stempin
Belgian Group Digestive Oncology( BGDO)
Outcome results
None listed