Radiation Therapy in Treating Women With Localized Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00107497|
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Radiation: radiation therapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Official Title:||Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST|
|Study Start Date :||January 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107497
|Sussex Cancer Centre at Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BE|
|Carlisle, England, United Kingdom, CA2 7HY|
|Cheltenham General Hospital|
|Cheltenham, England, United Kingdom, GL53 7AN|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Ipswich Hospital NHS Trust|
|Ipswich, England, United Kingdom, IP4 5PD|
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology NHS Trust|
|Merseyside, England, United Kingdom, CH63 4JY|
|Berkshire Cancer Centre at Royal Berkshire Hospital|
|Reading, England, United Kingdom, RG1 5AN|
|Royal Shrewsbury Hospital|
|Shrewsbury, England, United Kingdom, SY3 8XQ|
|University Hospital of North Staffordshire|
|Stoke-On-Trent, England, United Kingdom, ST4 7LN|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Torquay Devon, England, United Kingdom, TQ2 7AA|
|Royal Cornwall Hospital|
|Truro, Cornwall, England, United Kingdom, TR1 3LJ|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Worcester Royal Hospital|
|Worcester, England, United Kingdom, WR5 1DD|
|Worthing, England, United Kingdom, BN11 2DH|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Halton Hospital - North Cheshire Hospitals NHS Trust|
|Cheshire, United Kingdom, WA7 2DA|
|Hereford Hospitals NHS Trust|
|Hereford, United Kingdom, HR1 2ER|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|