| Source of record | UK Trials |
| ISRCTN | ISRCTN93845533 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | COLORAD |
| Public title | A Randomised Trial of Infusional 5-Fluorouracil and Concomitant Radiotherapy in Locally Advanced Rectal Cancer, Comparing Three and Six Months of Infusional 5-Fluorouracil |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Rectum |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically verified adenocarcinoma of the rectum, which is either:
a. Inoperable primary tumour
b. Locally recurrent tumour
c. Residual pelvic disease after resection as assessed either surgically or histopathologically
2. No evidence of metastatic disease
3. No past history of malignancy
4. No previous radiotherapy to the pelvis
5. Normal bone marrow, liver and renal function
6. No concurrent severe or life threatening illness |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 11/11/1994 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive continuous infusional 5-fluorouracil for 12 weeks plus radiotherapy to the pelvis, minimum 45 Gy given in twenty-five fractions over 5 weeks to start at the beginning of the 5th week of chemotherapy.
Depending upon the initial randomisation, patients receive either:
1. Group One: Continuous infusional 5-fluorouracil for a further 12 weeks.
2. Group Two: No further chemotherapy with 5-fluorouracil. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Royal Marsden Hospital |
| Sponsor name | Royal Marsden Hospital (UK) |
| Sponsor details | Downs Road
Sutton
United Kingdom
SM2 5PT |
| Sponsor telephone | +44 (0)20 8661 3156 |
| Sponsor fax | +44 (0)20 8643 9414 |
| Sponsor website | david.cunningham@rmh.nhs.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN93845533 |
| Date last extracted from ISRCTN register | 17/04/2008 |
