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