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ISRCTN
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ISRCTN68177645
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ClinicalTrials.gov identifier
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Public title
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A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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BR3002
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1997
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Anticipated end date
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31/12/1999
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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13/05/2008
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Date ISRCTN assigned
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01/07/2001
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