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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: |
ISRCTN21284267 |
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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 Pilot Randomised Trial Comparing Short Course Infusional 5-Fluourouracil with 5-Fluorouracil and Leucovorin as Adjuvant Therapy for Resected Colorectal Carcinoma
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Scientific title:
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Date of first enrolment:
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19/08/1993 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN21284267 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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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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Telephone:
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Email:
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Affiliation:
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Name:
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-
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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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Telephone:
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+44 (0) 20 7670 4723 |
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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. Histologically verified adenocarcinoma of colon or rectum, Dukes stages B or C
2. No evidence of residual local disease or metastatic disease as assessed at time of operation, clinical examination, and by ultrasound scanning
3. No past history of malignancy apart from non melanotic carcinoma of the skin or in-situ carcinoma of the cervix
4. No previous chemotherapy
5. Normal bone marrow, renal and liver function
6. Patients must be randomised within 10 weeks of surgery
7. No medical contraindications to treatment
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Colon, Rectum
Cancer
Colorectal
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Intervention(s)
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1. Regimen A: Continuous infusion of 5-fluorouracil over 12 weeks.
2. Regimen B: Folinic acid intravenous bolus injection, followed by 5-fluorouracil intravenous bolus injection given on 5 consecutive days and repeated every 28 days for six cycles
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Royal Marsden Hospital (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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