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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00595062
First received: January 4, 2008
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Radiation: Intra Operative Radiation Therapy (IORT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine tissue tolerance of the breast to a single intraoperative course of radiation. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • To establish feasibility of the technique in the operating room. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2002
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Radiation: Intra Operative Radiation Therapy (IORT)
Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595062

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Beryl McCormick, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00595062     History of Changes
Other Study ID Numbers: 02-101
Study First Received: January 4, 2008
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013