A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma
| ISRCTN | ISRCTN88796215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88796215 |
| Protocol serial number | NICCO CRCI |
| Sponsor | Wyeth-Lederle Ltd (UK) |
| Funders | Wyeth-Lederle Ltd (UK), Friends Of Montgomery House (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 19/01/2016
- 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 |
| Scientific title | A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colon, Rectal cancer |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil and folinic acid (leucovorin) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Key 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 |
| Key exclusion criteria | No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
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 |
