Clinical Trial: Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Accelerated Partial Breast Irradiation

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.


Detailed Summary:

OBJECTIVES:

  • To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
  • To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
  • To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.


Sponsor: University of Pennsylvania

Current Primary Outcome: Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
  • Site of disease recurrence (i.e., local, regional, or distant)
  • Time to recurrence
  • Time to locoregional recurrence


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 11, 2008
Date Started: January 2005
Date Completion:
Last Updated: July 8, 2009
Last Verified: July 2009