Clinical Trial: Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
Brief 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.
Detailed Summary:
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.
Sponsor: Dartmouth-Hitchcock Medical Center
Current Primary Outcome: Local recurrence rate [ Time Frame: 36 months ]
Original Primary Outcome:
Current Secondary Outcome: Survival rate [ Time Frame: 10 years ]
Original Secondary Outcome:
Information By: Dartmouth-Hitchcock Medical Center
Dates:
Date Received: November 1, 1999
Date Started: January 1998
Date Completion: December 2019
Last Updated: November 25, 2015
Last Verified: October 2015