Locally advanced rectal cancer Cancer Rectal cancer
Conditions
Interventions
Randomisation between:
Interventions:
Arm A: Control, standard follow-up
Arm B: six cycles at three weekly intervals (18 weeks):
a. Cap
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 and over 2. Histologically proven locally advanced rectal carcinoma 3. Pre-operative fluoropyrimidine based chemoradiation, minimum dose 45 Gy 4. Complete resection of primary tumour with clear margins 5. Able to start treatment within 12 weeks of surgery 6. Normal Full Blood Counts (FBCs), Urea and Electrolytes (U+Es) and Liver Function Tests (LFTs) 7. Creatinine clearance more than or equal to 50 ml/min 8. World Health Organisation performance status less than two 9. Patient consent
Exclusion criteria
Exclusion criteria: 1. Unsuitable for chemotherapy: a. known DPD deficiency b. hypersensitivity to platinum c. not recovered from surgery d. peripheral neuropathy e. moderate or severe renal impairment f. malabsorbtion syndrome 2. Prior oxaliplatin, irinotecan and mitomycin 3. Taking warfarinor antiviral agents 4. Previous malignancies or serious uncontrolled medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three year disease free survival of 85% power to detect a 10% increase i.e. 40% to 50%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Toxicity | — |
Countries
England, United Kingdom
Outcome results
None listed