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 |
|---|
