Colorectal cancer Cancer Malignant neoplasm of colon
Conditions
Interventions
1. Resection of the asymptomatic primary tumour prior to chemotherapy
2. Chemotherapy alone
There is no prescribed treatment in this trial. The chemotherapy regimen is
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven colorectal cancer 2. Metastases which are unresectable at presentation in the opinion of the appropriate multi-disciplinary team (MDT) 3. Primary tumour that in the MDT's opinion does not require immediate or emergency surgery or intervention 4. Patients who are referred for prophylactic colonic stents are eligible 5. Patient considered fit for systemic chemotherapy and surgery as determined by the local colorectal cancer MDT 6. Adequate full blood count (haemoglobin [Hb] greater than 10.0 g/dl; white blood cell count [WBC] greater than 3.0 x 10^9/L; platelets [Plts] greater than 100 x 10^9/L) 7. Adequate renal biochemistry: calculated glomerular filtration rate (GFR) greater than 50 ml/min using the Wright formula or measured by ethylenediaminetetraacetic acid (EDTA) clearance 8. Adequate hepatobiliary function: bilirubin less than 25 mmol/l 9. World Health Organization (WHO) performance status of 0 or 1 10. If female and of childbearing potential, must have a negative pregnancy test prior to trial entry and agree to avoid pregnancy during the trial 11. Patients over 18 years of age (either sex) able and willing to provide written informed consent for the trial and able to comply with treatment and follow-up schedule
Exclusion criteria
Exclusion criteria: 1. Serious co-morbidity precluding systemic chemotherapy 2. Unresectable primary tumour 3. Unequivocal extensive peritoneal metastases 4. History of malignant disease in the preceding five years with the exception of non-melanomatous skin cancer and in situ cervical cancer 5. Serious medical co-morbidity, e.g. uncontrolled inflammatory bowel disease, uncontrolled angina or recent (less than six months) myocardial infarction, another serious medical condition judged to compromise ability to tolerate chemotherapy and/or surgery 6. Less than 18 years of age 7. Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Patients will be followed up every 3 months until death for survival and adverse events related to surgery or chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morbidity of chemotherapy and surgery 2. Quality of life, assessed at 3 months and 6 months only 3. Economic evaluation Patients will be followed up every 3 months until death for survival and adverse events related to surgery or chemotherapy. | — |
Countries
United Kingdom
Outcome results
None listed