Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00595062
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 51
- Starts
- 2002-10-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-12-22
Who can join
Age: 60 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Core biopsy or prior open biopsy to establish the diagnosis.
- Over age 60.
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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