Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.
- Conditions
- Cancer - Bowel - Back passage (rectum) or large bowel (colon)Colon Cancer
- Registration Number
- ACTRN12609000662268
- Lead Sponsor
- Australasian Gastrointestinal Trials Group (AGITG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 213
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.[During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.]
- Secondary Outcome Measures
Name Time Method Overall survival.[Every 3 months until end of year 1 then 6 monthly until end of year 2 and yearly after that for seven years from date of first patient randomised into study.];Toxicity, assessed through physical examination and patient reports.[Arm A = 24 weeks of treatment patients will be assessed for toxicity at each visit during treament period and at 4 weeks post treatment. Arm B = 12 weeks of treament patients will be assessed for toxicity at each visit during treament, 4 weeks post treatment and monthly up to end of month 6 post randomisation.];Quality of life<br>assessed by completion of Quality of Life Questionnaires[Prior to randomisation, prior to each treamtent cycle, monthly for 3 months after 12 weeks of treatment in Arm-B and both arms at 9 and 12 months on study,]