Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Richard J. Barth

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003404
Information obtained from ClinicalTrials.gov on December 14, 2011

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