Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast
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.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors|
- Local recurrence rate [ Time Frame: 36 months ]
- Survival rate [ Time Frame: 10 years ]
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
|Experimental: Radiation||Procedure: adjuvant therapy Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003404
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Richard J. Barth, MD||Norris Cotton Cancer Center|