Breast Cancer Clinical Trial
Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.
Full Description
OBJECTIVES:
Primary
Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.
Secondary
Determine the long-term cosmetic result and quality of life of patients treated with this regimen.
Determine the long-term local control in patients treated with this regimen.
OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.
Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.
Patients are followed at 6 weeks and then every six months for 5 years.
PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the breast
Invasive or in-situ disease
Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease
Treated with breast-conserving surgery within the past 8 weeks
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Not specified
Menopausal status
Not specified
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3
Hepatic
Not specified
Renal
Not specified
Other
No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
No active systemic lupus
No history of scleroderma
No other medical or psychiatric condition that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No more than 6 weeks since prior adjuvant systemic chemotherapy
No concurrent chemotherapy
Endocrine therapy
Not specified
Radiotherapy
No prior radiotherapy to the breast
Surgery
See Disease Characteristics
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There is 1 Location for this study
Philadelphia Pennsylvania, 19111, United States
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