Clinical Trial: Single Fraction Intraoperative Radiotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial

Brief Summary: This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Detailed Summary: For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.
Sponsor: St. Joseph Hospital of Orange

Current Primary Outcome: Toxicity Assessment [ Time Frame: 5 years ]

Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:

  • End of initial surgical phase: Week 1, 4
  • First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cosmetic Evaluation [ Time Frame: 5 years ]

    Assessment of cosmetic outcome according to 5-point scoring system

    • Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
    • At yearly follow-up (photodocumentation in standardized positions) for 5 years
  • Recurrence Assessment [ Time Frame: 5 years ]
    Recurrence is assessed at month 6, 12, 24, 36, 48, 60


Original Secondary Outcome: Same as current

Information By: St. Joseph Hospital of Orange

Dates:
Date Received: September 12, 2012
Date Started: February 2012
Date Completion: February 2022
Last Updated: October 14, 2014
Last Verified: October 2014