Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
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.
연구 개요
상세 설명
OBJECTIVES:
- 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.
연구 유형
단계
- 3단계
연락처 및 위치
연구 장소
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Carlisle, 영국, CA2 7HY
- Cumberland Infirmary
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Portsmouth Hants, 영국, PO3 6AD
- Saint Mary's Hospital
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Preston, 영국, PR2 9HT
- Royal Preston Hospital
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England
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Brighton, England, 영국, BN2 5BE
- Royal Sussex County Hospital
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Cambridge, England, 영국, CB2 2QQ
- Addenbrooke's NHS Trust
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Cheltenham, England, 영국, GL53 7AN
- Cheltenham General Hospital
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Exeter, England, 영국, EX2 5DW
- Royal Devon and Exeter Hospital
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Guildford, England, 영국, GU2 5XX
- Royal Surrey County Hospital
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Ipswich, England, 영국, IP4 5PD
- Ipswich Hospital NHS Trust
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Leicester, England, 영국, LE1 5WW
- University Hospitals of Leicester
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London, England, 영국, SE1 9RT
- Guy's and St. Thomas' Hospitals Trust
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Maidstone, England, 영국, ME16 9QQ
- Maidstone Hospital
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Manchester, England, 영국, M20 4BX
- Christie Hospital N.H.S. Trust
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Merseyside, England, 영국, L63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Middlesbrough, Cleveland, England, 영국, TS4 3BW
- South Tees Hospitals NHS Trust
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Midhurst, England, 영국, GU29 OBL
- King Edward VII Hospital
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Northwood, England, 영국, HA6 2RN
- Mount Vernon Hospital
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Norwich, England, 영국, NR1 3SR
- Norfolk & Norwich Hospital
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Nottingham, England, 영국, NG5 1PB
- Nottingham City Hospital NHS Trust
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Plymouth, England, 영국, PL6 8DH
- Derriford Hospital
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Reading, England, 영국, RG1 5AN
- Royal Berkshire Hospital
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Romford, England, 영국, RM7 OBE
- Oldchurch Hospital
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Sheffield, England, 영국, S1O 2SJ
- Weston Park Hospital
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Shrewsbury, England, 영국
- Royal Shrewsbury Hospital
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Stoke-On-Trent, England, 영국, ST4 7LN
- North Staffs Royal Infirmary
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Sutton, England, 영국, SM2 5PT
- Royal Marsden Hospital
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Torquay Devon, England, 영국, TQ2 7AA
- Torbay Hospital
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Westcliff-On-Sea, England, 영국
- Southend NHS Trust Hospital
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Wolverhampton, England, 영국, WV10 0QP
- New Cross Hospital
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Northern Ireland
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Belfast, Northern Ireland, 영국, BT8 8JR
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
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Scotland
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Dundee, Scotland, 영국, DD1 9SY
- Ninewells Hospital and Medical School
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Wales
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Cardiff, Wales, 영국, CF4 7XL
- Velindre Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
수사관
- 연구 의자: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust
간행물 및 유용한 링크
일반 간행물
- 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.
- 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. Erratum In: Breast. 2008 Feb;17(1):115. START Trial Management Group [added].
- 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.
- 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.
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