Breast Cancer Clinical Trial
Official title:
A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma
RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation
directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation
therapy in treating women who have undergone lumpectomy and axillary node dissection for
stage I or stage II breast cancer.
OBJECTIVES:
- Determine the technical feasibility and reproducibility of three-dimensional conformal
radiotherapy confined to the region of the lumpectomy cavity in women with stage I or
II breast cancer.
- Determine the cosmetic results in patients treated with this regimen.
- Determine the complication rates in patients treated with this regimen.
- Determine the local control rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning
within 8 weeks after surgery.
Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to
15.3 months.
;
Masking: Open Label, Primary Purpose: Treatment
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