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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595062
• Other study ID #: 02-101
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: December 21, 2015
• Start date: October 2002
• Est. completion date: July 2013

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2013
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Intra Operative Radiation Therapy (IORT)
Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine tissue tolerance of the breast to a single intraoperative course of radiation.		7 years	No
Primary	To establish feasibility of the technique in the operating room.		7 years	No
Secondary	overall survival		7 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center