Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer - Full Text View

Sponsored by:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005588

Purpose

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 different regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

Condition	Intervention	Phase
Breast Cancer	Procedure: radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Standardization of Breast Radiotherapy: Trial A - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 1999

Detailed Description:

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 3 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 fortnight (i.e., Monday/Wednesday/Friday/Tuesday/Thursday/Monday, etc.) for 13 fractions over 5 weeks for a total dose of 41.6 Gy.
Arm III: Patients receive radiotherapy as in arm II for a total dose of 39 Gy. A breast boost is recommended in all 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.

PROJECTED ACCRUAL: A total of 2,010 patients (670 per arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed invasive unilateral breast cancer that is considered operable
- 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005588

Locations

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

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

John R. Yarnold, MD, FRCR

Royal Marsden - Surrey

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Hopwood P, Haviland J, Mills J, Sumo G, M Bliss J. 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 Jan 18; [Epub ahead of print]

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.

Study ID Numbers:	CDR0000067662, STMG-STARTA, EU-99014
Study First Received:	May 2, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00005588
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009