- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00595062
Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
Time Frame: 7 years
|
7 years
|
To establish feasibility of the technique in the operating room.
Time Frame: 7 years
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 7 years
|
7 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beryl McCormick, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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