| Source of record | UK Trials |
| ISRCTN | ISRCTN88796215 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | NICCO CRCI |
| Public title | A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Colon, Rectal cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 18 to 80 years
2. World Health Organisation (WHO) performance status zero to two
3. Histological proof of colorectal adenocarcinoma
4. The entire colorectum must be visualised pre- or postoperatively to exclude synchronous carcinoma
5. Potentially curative surgery
6. Adjuvant treatment to be initiated within six weeks of surgery
7. Adequate bone marrow, renal and hepatic function
8. No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/2002 |
| Anticipated end date | 01/08/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | COLON CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses.
RECTAL CANCER: Following surgery patients are randomised to one of two groups:
1. Group A: No adjuvant therapy
2. Group B: Radiotherapy 4400 cGy in 22 daily fractions plus adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses. Radiotherapy to be given five days per week prior to or concurrent with chemotherapy. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Friends Of Montgomery House, Lederle Ltd (UK) |
| Sponsor name | Friends Of Montgomery House, Lederle Ltd |
| Sponsor details |
United Kingdom
|
| Sponsor website | http://www.wyeth.com/worldwide/united_kingdom.asp |
| 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 | ISRCTN88796215 |
| Date last extracted from ISRCTN register | 17/04/2008 |
