A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
18 Years
N/A
Female
Breast Cancer
Trial Information
A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local recurrence rate
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Richard J. Barth, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066410
NCT ID:
NCT00003404
Start Date:
January 1998
Completion Date:
December 2019
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- phyllodes tumor
- Breast Neoplasms
- Phyllodes Tumor
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
