Colonic Neoplasms
Conditions
Brief summary
Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients
Interventions
DRUGoxaliplatin
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven stage Dukes B2 (stage II: T3-T4 N0 M0) and C (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (\> 15 cm from the anal margin). * Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease * Patients must be entered in the study in order to start treatment within 7 weeks after surgery * Age 18-75 years old * Performance Status ≤ 2 (Karnofsky \> or = 60%) * No previous chemotherapy, immunotherapy or radiotherapy * No biological major abnormalities :Absolute neutrophil count \> 1.5 x 10\^9/l,Platelets ≥ 100 x 10\^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT \< 2 times the upper limit of the normal range,carcinoembryonic antigen \< 10 ng/ml. * Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs * Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children * Signed informed consent obtained prior to study entry
Exclusion criteria
* Pregnant or lactating women * Women of child bearing potential not using a contraceptive method * Previous cancer of the colon or rectum * Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years * Participation in another clinical trial with any investigational drug within 30 days prior to randomization * Peripheral neuropathy (NCI CTC \[National Cancer Institute Common Toxicity Criteria\] \> or = Grade I) * Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia * History of significant neurologic or psychiatric disorders * Active infection The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicity | from the inform consent signed up to the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| Overall distribution of intensity of adverse events | from the inform consnet signed up to the end of the study |
| Occurrence of particular adverse events and their intensities | from the inform consent signed up to the end of the study |
| Percent of patients completing study treatment | from the inform consent signed up to the end of the study |
| Percent of patients with grade 1, 2 and 3 neuropathy | at 28 days, 6 months and 12 months after last chemotherapy administration. |
| Occurrence of one or more adverse event in a patient | From the Informed Consent Form (ICF) signature to the end of the study |
| Delays in scheduled dosing | During the study conduct |
| Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment | during the study conduct |
| •Survival Analysis •Laboratory assay and vital signs ECOG and KPS | during the study conduct |
| Long term toxicity | during the study conduct |
| Percent of intended dose delivered for 5-FU/LV and Oxaliplatin | from the informed consent signed up to the end of the study |
Countries
China, Hong Kong, South Korea, Taiwan, Thailand
Outcome results
None listed