A randomised trial of infusional 5-fluorouracil and concomitant radiotherapy in locally advanced rectal cancer, comparing three and six months of infusional 5-fluorouracil
| ISRCTN | ISRCTN93845533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93845533 |
| Secondary identifying numbers | COLORAD |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific 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 |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Cancer of rectum |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1990 |
| Overall study end date | 11/11/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | 1. Histologically verified adenocarcinoma of the rectum, which is either: 1.1. Inoperable primary tumour 1.2. Locally recurrent tumour 1.3. 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 |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/01/1990 |
| Recruitment end date | 11/11/1994 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Marsden Hospital (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/01/2019: No publications found. All search options exhausted.
18/01/2016: no publications found on PubMed.
