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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN27478455 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised study of continuous infusional 5-fluorouracil with or without bolus mitomycin-C in patients with advanced colorectal cancer
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Scientific title:
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Date of first enrolment:
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13/03/1995 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN27478455 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Colon, Rectal cancer
Cancer
Malignant neoplasm of other and ill-defined digestive organs
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Intervention(s)
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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: continuous infusion 5-fluorouracil given as above plus mitomycin-C given every 6 weeks for two courses and to a total of four courses in responding patients or patients with stable disease.
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Primary Outcome(s)
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Added 05/08/09:
1. tumour response
2. survival
3. toxicity
4. quality of life (QoL)
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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COMBAT COIRE
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Source(s) of Monetary Support
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The Royal Marsden NHS Foundation Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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