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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
START

Standardisation of Breast Radiotherapy (START) Trial


Topic
Cancer
Portfolio Eligibility
Funded by UKCRC partner
ISRCTN 59368779
EudraCT
MREC N° MREC 98/96
UKCRN ID 629
WHO ID
Research Summary
To test the effects of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, loco-regional tumour control, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.
Study Type Interventional
Design Type Treatment
Disease(s) Breast
Phase N/A
Current Status Closed - in follow-up
Closure Date25/10/2002
Sample Size 4000
Accrual to Date
111%
Geographical Scope UK Multi-Centre
Lead Country Unknown (also active in England)
Main Inclusion Criteria
Age 18 yr. or over Operable unilateral breast cancer (T1-3, N0-1, M0 at presentation) Histological confirmation of invasive carcinoma Complete macroscopic excision of tumour by breast conserving or mastectomy (ideally no microscopic evidence of invasive or in situ cancer at, or within 1mm, a resection margin) Patient consents to be part of the study and is available for follow-up No immediate breast reconstruction Ineligibility : patients requiring axillary radiotherapy after greater than a Level 1 axillary dissection or after >10 lymph nodes have been removed
Main Exclusion Criteria
not specified
Chief Investigator(s)
Prof John Yarnold
Further details, please contact
Mr Mark Sydenham

Institute of Cancer Research
Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
UNITED KINGDOM

Tel: 0208 722 4104
Mark.Sydenham@icr.ac.uk
Funder(s) Medical Research Council
NIHR - Health Technology Assessment Programme (HTA)
Cancer Research UK
Sponsor(s) Institute of Cancer Research




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