Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
NCT ID: NCT00005587
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-01-31
2004-06-30
Brief Summary
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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.
Detailed Description
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* Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.
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.
* Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.
* Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive unilateral breast cancer
* T1-3, N0-1, M0 at presentation
* Complete macroscopic excision of tumor by breast conserving surgery or mastectomy
* No immediate breast reconstruction
* No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed
* Not enrolled on SECRAB or OSCAR trials
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
* Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor
Biologic therapy:
* Not specified
Chemotherapy:
* At least 2 weeks since prior cytotoxic agents
* No concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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John R. Yarnold, MD, FRCR
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Sussex County Hospital
Brighton, England, United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Royal Surrey County Hospital
Guildford, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
University Hospitals of Leicester
Leicester, England, United Kingdom
Guy's and St. Thomas' Hospitals Trust
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, United Kingdom
King Edward VII Hospital
Midhurst, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk & Norwich Hospital
Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Royal Berkshire Hospital
Reading, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
North Staffs Royal Infirmary
Stoke-on-Trent, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Southend NHS Trust Hospital
Westcliff-on-Sea, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Velindre Hospital
Cardiff, Wales, United Kingdom
Cumberland Infirmary
Carlisle, , United Kingdom
Saint Mary's Hospital
Portsmouth Hants, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncol. 2010 Mar;11(3):231-40. doi: 10.1016/S1470-2045(09)70382-1. Epub 2010 Feb 6.
START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19.
Hopwood P, Haviland J, Mills J, Sumo G, M Bliss J; START Trial Management Group. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radiotherapy Trial). Breast. 2007 Jun;16(3):241-51. doi: 10.1016/j.breast.2006.11.003. Epub 2007 Jan 19.
Venables K, Miles EA, Aird EG, Hoskin PJ; START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol. 2004 Jun;71(3):303-10. doi: 10.1016/j.radonc.2004.02.008.
Other Identifiers
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STMG-STARTB
Identifier Type: -
Identifier Source: secondary_id
EU-99015
Identifier Type: -
Identifier Source: secondary_id
CDR0000067661
Identifier Type: -
Identifier Source: org_study_id