Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- To determine tissue tolerance of the breast to a single intraoperative course of radiation.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding breast tissue is at greater risk for developing breast recurrences. This treatment may be as effective as the conventional 5-6week radiation treatment in reducing the risk of further local recurrences after breast-conserving surgery.
Through this study, we would like to confirm that this procedure is a safe alternative to conventional breast radiation, with no additional side effects when compared with the conventional surgery and radiation therapy.
Detailed Description
This pilot trial will evaluate the feasibility of intra operative radiation therapy (IORT) given in one fraction at the time of wide local excision as the only adjuvant radiation treatment in a group of patients with early-stage invasive breast cancer. This study will enroll 60 women, older than 60 years of age, with breast cancer not more than 2 cm in size and without evident additional tumoral foci around the tumor or in other areas of the breast. An MSK radiologist will review your mammography to be sure you qualify for this study. You may be asked to undergo additional mammography or other examinations, such as breast ultrasound in order to verify that the tumor is located in a single quadrant of the breast. Some of these procedures are routinely performed in all candidates for conservative breast surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Core biopsy or prior open biopsy to establish the diagnosis.
- •No physical or imaging evidence of multicentricity or multifocality.
- •Size equal or less than 2.0 cm radiographically, clinically node negative.
- •Patients scheduled for breast conserving surgery
Exclusion Criteria
- •Patients younger than 61 years
- •Patients with evidence of multicentric or multifocal disease seen on imaging (mammography )
- •Patients with a lesion exceeding 2 cm radiographically
- •Paget's disease or pure DCIS without invasive ductal carcinoma
- •Histotype not inclusive of ductal carcinoma
- •Condition precluding radiation therapy
- •Condition precluding regular follow-up
- •Evident dimpling of the skin above the tumor
- •Usual contraindications for BCS
Outcomes
Primary Outcomes
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
Time Frame: 7 years
To establish feasibility of the technique in the operating room.
Time Frame: 7 years
Secondary Outcomes
- overall survival(7 years)