Spots Global Cancer Trial Database for Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study

Study Description

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.

Keywords

Eligibility

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial