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 |
| Protocol serial number | COLORAD |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 11/11/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 11/11/1994 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2019: No publications found. All search options exhausted.
18/01/2016: no publications found on PubMed.
