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Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer



Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer

For Condition: stage 2 breast cancer,stage 3A breast cancer,intraductal breast carcinoma,breast cancer in situ,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer
Details: OBJECTIVES: - Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast. - Determine the local recurrence rates in patients treated with this regimen. - Determine the cosmetic outcome in patients treated with this regimen. OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks. Patients are followed at 1 month and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast - Primary tumor classified as T1, T2, or T3 - Candidate for breast-conserving surgery - Must have undergone lumpectomy with negative margins or minimal margin involvement - Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection - No evidence of metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Adult Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC greater than 3,500/mm^3 - Granulocyte count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Not specified Renal - Not specified Other - Not pregnant - No other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer - Prior contralateral breast cancer allowed if curatively treated more than 5 years previously - No severe psychiatric or medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the involved breast Surgery - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ShelliHanks,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center
Cleveland,  Ohio,  44106
United States
 


Additional Information:
Study ID Numbers:  CDR0000270347;  CWRU-ICC-4102
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054301

Other Stage 2 Breast Cancer Studies:
1. Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer

2. Radiation Therapy After Surgery in Treating Patients With Phyllodes Tumor of the Breast

3. Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer

4. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

5. Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

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