Colon, Rectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
1. Regimen one: continuous infusion 5-fluorouracil. The infusion will be given for 12 weeks and for a further 12 weeks in responding patients or patients with stable disease.
2. Regimen two: continuou
Sponsors
The Royal Marsden NHS Foundation Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological evidence of metastatic adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease 3. Patients with no measurable disease 4. Adequate bone marrow function 5. Serum creatinine within normal range 6. Life expectancy of greater than 3 months 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion criteria
Exclusion criteria: 1. History of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix 2. Prior treatment with any cytotoxic agent except adjuvant chemotherapy completed more than 12 months from randomisation 3. Intracerebral metastases or meningeal carcinomatosis 4. Medical contraindications to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 05/08/09: 1. tumour response 2. survival 3. toxicity 4. quality of life (QoL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed