Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
NCT ID: NCT00003404
Last Updated: 2019-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
1998-01-31
2008-11-17
Brief Summary
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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.
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Detailed Description
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* 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.
METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adjuvant Radiotherapy
Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Adjuvant Radiotherapy
Adjuvant radiation therapy
Interventions
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Adjuvant Radiotherapy
Adjuvant radiation therapy
Eligibility Criteria
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Inclusion Criteria
1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
2. Must have been excised with breast-conserving resection and no positive margins
3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
5. Hormone receptor status: Not specified
PATIENT CHARACTERISTICS:
1. Age: 18 and over
2. Sex: Female
3. Menopausal status: Not specified
4. Performance status: Not specified
5. Life expectancy: Not specified
6. Hematopoietic: Not specified
7. Hepatic: Not specified
8. Renal: Not specified
9. Other:
1. Not pregnant
2. Negative pregnancy test
3. Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
1. Biologic therapy: Not specified
2. Chemotherapy: Not specified
3. Endocrine therapy: Not specified
4. Radiotherapy: No prior radiotherapy to the ipsilateral breast
5. Surgery: See Disease Characteristics
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Richard J. Barth,Jr.
Chief, Section of General Surgery
Principal Investigators
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Richard J. Barth, MD
Role: STUDY_CHAIR
Norris Cotton Cancer Center
Locations
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8.
Other Identifiers
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DMS-9801
Identifier Type: -
Identifier Source: secondary_id
DMS-12752
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1442
Identifier Type: -
Identifier Source: secondary_id
D9801 CDR0000066410
Identifier Type: -
Identifier Source: org_study_id
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