A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer
| ISRCTN | ISRCTN68177645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68177645 |
| Protocol serial number | BR3002 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 23/02/2015
- 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
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 collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Following surgery to remove the tumour patients are randomised into one of six treatment groups: 1. Group A: Tamoxifen daily for 2 years 2. Group B: Tamoxifen daily until recurrence 3. Group C: Short radiotherapy plus tamoxifen daily for 2 years 4. Group D: Short radiotherapy plus tamoxifen daily until recurrence 5. Group E: Long radiotherapy plus tamoxifen daily for 2 years 6. Group F: Long radiotherapy plus tamoxifen daily until recurrence SYSTEMIC TREATMENT: Tamoxifen 20 mg daily to start immediately following surgery POST-OPERATIVE RADIOTHERAPY: Short Radiotherapy: 40 Gy in fifteen daily fractions given over 3 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions. Long Radiotherapy: 50 Gy in twenty-five daily fractions given over 5 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Histologically proven adenocarcinoma of breast 2. Tumour size <5 cm 3. No clinically palpable axillary nodes 4.. Have had an operation resulting in a cosmetically satisfactory breast 5. No evidence of systemic metastases 6. No previous treatment for a malignancy by radiotherapy or chemotherapy 7. Patients with Paget's disease of the nipple, bilateral breast cancer or lymphoedema of the breast are excluded 8. No previous or co-existing malignancies, except basal cell carcinoma of skin and in-situ carcinoma of cervix 9. Patients must be fit enough to receive any of the specified treatments |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/1999 |
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 | |
| IPD sharing plan |
