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
50 Years
N/A
Female
Breast Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
John R. Yarnold, MD, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000417730
NCT ID:
NCT00107497
Start Date:
January 2005
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
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