None listed
Conditions
Brief summary
This study will evaluate the safety and efficacy of post-operative chemotherapy for 12 weeks versus 24 weeks in patients with locally advanced colon cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have stage III colon cancer which has been fully resected (i.e. removed by surgery). You should not have undergone any previous chemotherapy for your cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo chemotherapy for 12 weeks. Participants in the other group will undergo chemotherapy for 24 weeks. Chemotherapy will either be with the drugs oxaliplatin/5-FU or oxaliplatin/capecitabine depending on the preference of your treating doctor. Participants will be regularly assessed for a period of up to 7 years to determine disease free survival, overall survival, toxicity, cost effectiveness and quality of life.
Interventions
Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox).
Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxa
Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site. Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks.
Sponsors
Australasian Gastrointestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients with fully resected stage III colon cancer 2. No evidence of residual or metastatic disease. 3. Patients must be randomised within 10 weeks of surgery. 4. World Health Organisation(WHO) Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1 5. Life expectancy >5 years with reference to non-cancer related diseases. 6 Written informed consent 7. Carcinoembryonic Antigen (CEA) within normal limits
Exclusion criteria
1. Previous chemotherapy. 2. previous abdomino-pelvic radiotherapy. 3. moderate/severe renal impairment, Glomerular Filtration Rate (GFR<30 ml/min) as calculated by the Cockcroft and Gault equation. 4. absolute neutrophil count <1.5x109/L 5. Platelet count <100x10 9/L 6. Haemoglobin <9g/dL 7. Aspartate aminotransferase/alanine aminotransferase > 2.5 x upper limit of normal. 8. Clinically significant cardiovascular disease. (i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension.) 9. Pregnancy/lactation or of child bearing potential and not using medically approved contraception. 10. previous malignancy 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 5 years. 11. known or suspected dihydropyrimidine dehydrogenase deficiency (DPD)
Outcome results
None listed