Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments adjuvant therapy, radiation therapy
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adjuvant therapy
radiation therapy

Primary Outcomes

Measure
Local recurrence rate
time frame: 36 months

Secondary Outcomes

Measure
Survival rate
time frame: 10 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center.