Radiation Therapy in Treating Women With Localized Breast Cancer
NCT ID: NCT00107497
Last Updated: 2019-02-27
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
NA
917 participants
INTERVENTIONAL
2004-10-05
2017-03-09
Brief Summary
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PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
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Detailed Description
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* Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
* Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
* Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
* Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
* Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
50Gy in 25 fractions of radiation therapy over 5 weeks
Radiation therapy
Test group 1
30Gy in 5 fractions of radiation therapy over 5 weeks
Radiation therapy
Test group 2
28.5Gy in 5 fractions of radiation therapy over 5 weeks
Radiation therapy
Interventions
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Radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of invasive carcinoma of the breast
* Localized disease
* Pathological tumor size \< 3.0 cm in diameter
* Axillary node negative
* At average or low risk of local tumor recurrence
* Must have undergone prior breast-preserving surgery
* No prior mastectomy
* Complete microscopic resection of tumor
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 50 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
Other
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior neoadjuvant or adjuvant cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent lymphatic radiotherapy
* No concurrent radiotherapy boost to the breast
Surgery
* See Disease Characteristics
50 Years
120 Years
FEMALE
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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John R. Yarnold, MD, FRCR
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Worcester Royal Hospital
Worcester, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Halton Hospital - North Cheshire Hospitals NHS Trust
Cheshire, , United Kingdom
Hereford Hospitals NHS Trust
Hereford, , United Kingdom
Countries
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References
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Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
Related Links
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First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015), Radiotherapy and Oncology, Volume 100, Issue 1, 2011, Pages 93 - 100
Other Identifiers
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ICR-04/MRE06/17
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDR0000417730
Identifier Type: -
Identifier Source: org_study_id
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