NCT00263055CompletedPhase 4
Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Locations
- 5
- Primary Endpoint
- Occurrence of dose-limiting toxicity
Study Overview
Brief Summary
Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Occurrence of dose-limiting toxicity
Time Frame: from the inform consent signed up to the end of the study
Secondary Outcomes
- Percent of patients with grade 1, 2 and 3 neuropathy(at 28 days, 6 months and 12 months after last chemotherapy administration.)
- Percent of intended dose delivered for 5-FU/LV and Oxaliplatin(from the informed consent signed up 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)
- Occurrence of one or more adverse event in a patient(From the Informed Consent Form (ICF) signature to the end of the study)
- 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)
Investigators
Study Sites (5)
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