Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Oct 2002
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 22, 2015
December 1, 2015
3.3 years
January 4, 2008
December 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
7 years
To establish feasibility of the technique in the operating room.
7 years
Secondary Outcomes (1)
overall survival
7 years
Study Arms (1)
1
EXPERIMENTALInterventions
Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beryl McCormick, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
October 1, 2002
Primary Completion
January 1, 2006
Study Completion
July 1, 2013
Last Updated
December 22, 2015
Record last verified: 2015-12