Metastatic colorectal cancer Cancer Colorectal
Conditions
Interventions
Chemotherapy
The Oxaliplatin regimens used in the trial can be selected on a per patient basis, but prior to knowledge of the treatment randomisation. This conforms with the NICE guidance regarding al
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed colorectal adenocarcinoma: - either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease - or histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour 2. Inoperable metastatic or locoregional disease. Patients who are currently eligible for combination first-line chemotherapy prior to liver resection under National Institute for Clinical Excellence (NICE) guidance are ineligible for this study. 3. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) 4. No previous systemic palliative chemotherapy for metastatic disease 5. Adjuvant chemotherapy with 5-Fluorouracil (5FU) +/- folinic acid (FA), Capecitabine or irinotecan may have been given, if completed >6 months prior to trial entry 6. Rectal chemoradiotherapy with 5FU +/- FA may have been given, if completed >1 month prior to trial entry 7. World Health Organistion (WHO) performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy 8. Baseline laboratory tests (within 1 week prior to randomisation): White blood cell count (WBC) =4 x 10^9/l, neutrophils =1.5 x 10^9/l and platelet count >150 x 10^9/l. Serum bilirubin =1.25 x upper limit of normal (ULN), alkaline phosphatase =5 x ULN, and serum transaminase (either aspartate transaminase [AST] or alanine transaminase [ALT]) =3 x ULN. Estimated creatinine clearance >50 ml/min or measured glomerular filtration rate (GFR) (ethylene diamine tetraacetic acid [EDTA] clearance) >50 ml/min. 9. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions 10. Consent to allow surplus pathological material to be analysed for epidermal growth factor receptor (EGFR) testing
Exclusion criteria
Exclusion criteria: 1. Patients who are unfit for the chemotherapy regimens in this protocol e.g. Severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent myocardial infarction [MI], i.e. in previous 3 months) likely to interfere with protocol treatments Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication Partial or complete bowel obstruction Pre-existing neuropathy (>grade 1) 2. Patients requiring ongoing treatment with a contraindicated concomitant medication 3. Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN treatment or assessment of response
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
United Kingdom
Outcome results
None listed