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Clinical Trials/NCT00107497
NCT00107497
Completed
Not Applicable

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

Institute of Cancer Research, United Kingdom19 sites in 1 country917 target enrollmentOctober 5, 2004
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Institute of Cancer Research, United Kingdom
Enrollment
917
Locations
19
Primary Endpoint
Change in photographic breast appearance
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

OBJECTIVES: * 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.

Registry
clinicaltrials.gov
Start Date
October 5, 2004
End Date
March 9, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Institute of Cancer Research, United Kingdom
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in photographic breast appearance

Time Frame: 2 years post randomisation

Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph

Study Sites (19)

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