Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
60 Years
N/A
Female
Breast Cancer
Trial Information
Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
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.
Inclusion Criteria:
- 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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
Outcome Time Frame:
7 years
Safety Issue:
No
Principal Investigator
Beryl McCormick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
02-101
NCT ID:
NCT00595062
Start Date:
October 2002
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- Breast
- Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
