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| ID | Type | Description | Link |
|---|---|---|---|
| ICR-04/MRE06/17 | Other Grant/Funding Number | UK MREC |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 50Gy in 25 fractions of radiation therapy over 5 weeks |
|
| Test group 1 | Active Comparator | 30Gy in 5 fractions of radiation therapy over 5 weeks |
|
| Test group 2 | Active Comparator | 28.5Gy in 5 fractions of radiation therapy over 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in photographic breast appearance | Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph | 2 years post randomisation |
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DISEASE CHARACTERISTICS:
Diagnosis of invasive carcinoma of the breast
Localized disease
At average or low risk of local tumor recurrence
Must have undergone prior breast-preserving surgery
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| John R. Yarnold, MD, FRCR | Royal Marsden NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England | BN2 5BE | United Kingdom | ||
| Cumberland Infirmary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32663119 | Derived | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| Carlisle |
| England |
| CA2 7HY |
| United Kingdom |
| Cheltenham General Hospital | Cheltenham | England | GL53 7AN | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | England | EX2 5DW | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | England | IP4 5PD | United Kingdom |
| Christie Hospital NHS Trust | Manchester | England | M20 4BX | United Kingdom |
| Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | CH63 4JY | United Kingdom |
| Berkshire Cancer Centre at Royal Berkshire Hospital | Reading | England | RG1 5AN | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | England | SY3 8XQ | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | England | ST4 7LN | United Kingdom |
| Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Torbay Hospital | Torquay Devon | England | TQ2 7AA | United Kingdom |
| Royal Cornwall Hospital | Truro, Cornwall | England | TR1 3LJ | United Kingdom |
| Southend University Hospital NHS Foundation Trust | Westcliff-on-Sea | England | SS0 0RY | United Kingdom |
| Worcester Royal Hospital | Worcester | England | WR5 1DD | United Kingdom |
| Worthing Hospital | Worthing | England | BN11 2DH | United Kingdom |
| Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | CF14 2TL | United Kingdom |
| Halton Hospital - North Cheshire Hospitals NHS Trust | Cheshire | WA7 2DA | United Kingdom |
| Hereford Hospitals NHS Trust | Hereford | HR1 2ER | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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