Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
This trial is active, not recruiting.
|Treatments||adjuvant therapy, radiation therapy|
|Sponsor||Dartmouth-Hitchcock Medical Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 1998|
|End date||December 2019|
|Trial size||50 participants|
|Trial identifier||NCT00003404, CDR0000066410, DMS-12752, DMS-9801, NCI-V98-1442, P30CA023108|
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: This phase II trial is studying how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.
|Intervention model||single group assignment|
Local recurrence rate
time frame: 36 months
time frame: 10 years
Female participants from 18 years up to 120 years old.
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
|Official title||A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors|
|Description||OBJECTIVES: - Determine the local recurrence rate in women 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.|
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