3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive breast cancer Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1) Unifocal disease (single focus that can be encompassed by one lumpectomy) The following histologies are eligible: Invasive ductal Medullary Papillary Colloid (mucinous) Tubular No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS) No nonepithelial breast malignancies such as sarcoma or lymphoma Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy Six surgical clips in place delineating the margins of the tylectomy cavity Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy No more than 3 positive axillary nodes No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition: More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue Intraductal carcinoma with microinvasion No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer No evidence of suspicious microcalcifications No Paget's disease of the nipple No skin involvement by disease, regardless of tumor size No distant metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status Not specified Life expectancy At least 2 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Technically suitable for breast radiotherapy No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) No other medical condition that would limit life expectancy No psychiatric or addictive disorders that would preclude giving informed consent No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 2 weeks since prior chemotherapy No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy Endocrine therapy Concurrent anastrozole or tamoxifen allowed Radiotherapy No prior radiotherapy for the current malignancy Surgery See Disease Characteristics Other No prior nonhormonal therapy for the current malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer