A randomised study of continuous infusional 5-fluorouracil with or without bolus mitomycin-C in patients with advanced colorectal cancer
- Conditions
- Colon, Rectal cancerCancerMalignant neoplasm of other and ill-defined digestive organs
- Registration Number
- ISRCTN27478455
- Lead Sponsor
- The Royal Marsden NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Added 05/08/09:<br>1. tumour response<br>2. survival<br>3. toxicity<br>4. quality of life (QoL)
- Secondary Outcome Measures
Name Time Method ot provided at time of registration