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 |
| Secondary identifying numbers | BR3002 |
- 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
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 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1997 |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
