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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005587 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer |
Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 2 treatment arms.
A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.
Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.
Patients are followed annually for up to 20 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive unilateral breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom | |
Cumberland Infirmary | |
Carlisle, United Kingdom, CA2 7HY | |
Royal Preston Hospital | |
Preston, United Kingdom, PR2 9HT | |
Saint Mary's Hospital | |
Portsmouth Hants, United Kingdom, PO3 6AD | |
United Kingdom, England | |
Addenbrooke's NHS Trust | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Cheltenham General Hospital | |
Cheltenham, England, United Kingdom, GL53 7AN | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 4BX | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, L63 4JY | |
Derriford Hospital | |
Plymouth, England, United Kingdom, PL6 8DH | |
North Staffs Royal Infirmary | |
Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
Ipswich Hospital NHS Trust | |
Ipswich, England, United Kingdom, IP4 5PD | |
King Edward VII Hospital | |
Midhurst, England, United Kingdom, GU29 OBL | |
Maidstone Hospital | |
Maidstone, England, United Kingdom, ME16 9QQ | |
Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN | |
New Cross Hospital | |
Wolverhampton, England, United Kingdom, WV10 0QP | |
Norfolk & Norwich Hospital | |
Norwich, England, United Kingdom, NR1 3SR | |
Guy's and St. Thomas' Hospitals Trust | |
London, England, United Kingdom, SE1 9RT | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Oldchurch Hospital | |
Romford, England, United Kingdom, RM7 OBE | |
Royal Berkshire Hospital | |
Reading, England, United Kingdom, RG1 5AN | |
Royal Devon and Exeter Hospital | |
Exeter, England, United Kingdom, EX2 5DW | |
Royal Sussex County Hospital | |
Brighton, England, United Kingdom, BN2 5BE | |
Royal Shrewsbury Hospital | |
Shrewsbury, England, United Kingdom | |
Royal Surrey County Hospital | |
Guildford, England, United Kingdom, GU2 5XX | |
Royal Marsden Hospital | |
Sutton, England, United Kingdom, SM2 5PT | |
South Tees Hospitals NHS Trust | |
Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
Southend NHS Trust Hospital | |
Westcliff-On-Sea, England, United Kingdom | |
Torbay Hospital | |
Torquay Devon, England, United Kingdom, TQ2 7AA | |
University Hospitals of Leicester | |
Leicester, England, United Kingdom, LE1 5WW | |
Weston Park Hospital | |
Sheffield, England, United Kingdom, S1O 2SJ | |
United Kingdom, Northern Ireland | |
Belfast City Hospital Trust Incorporating Belvoir Park Hospital | |
Belfast, Northern Ireland, United Kingdom, BT8 8JR | |
United Kingdom, Scotland | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY | |
United Kingdom, Wales | |
Velindre Hospital | |
Cardiff, Wales, United Kingdom, CF4 7XL |
Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000067661, STMG-STARTB, EU-99015 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005587 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |