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



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

For Condition: Phyllodes Tumor,breast cancer in situ,recurrent breast cancer
Status: Recruiting
Sponsor(s): Norris Cotton Cancer Center ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast. PURPOSE: Phase II trial to study the effectiveness of radiation therapy after surgery in treating patients with phyllodes tumor of the breast.
Details: OBJECTIVES: - Determine the local recurrence rate in patients with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy. - Determine the survival rate in patients treated with this regimen. OUTLINE: Within 12 weeks after prior local excision or breast reexcision, patients undergo adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients are followed every 6 months for 10 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 6-7 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following: - Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia - Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia - Must have been excised with breast-conserving resection - No positive margins - Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision - No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 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: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the ipsilateral breast Surgery - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardBarth,  Study Chair,  Norris Cotton Cancer Center

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Richard  Barth 603-650-7903


Additional Information:
Study ID Numbers:
  CDR0000066410;  DMS-9801,DMS-12752,NCI-V98-1442
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003404

Other Phyllodes Tumor Studies:
1. Radiation Therapy After Surgery in Treating Patients With Phyllodes Tumor of the Breast

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

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