Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: adjuvant therapy; Radiation: brachytherapy; Radiation: 3-dimensional conformal radiation therapy

• Registration Number: NCT00527293
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Detailed Description

OBJECTIVES:

* To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.

* To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.

* To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.

* To evaluate wound healing and overall complication rate after partial breast irradiation.

* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.

OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.

After completion of study therapy, patients are followed periodically for up to 5 years.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2010-10
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MammoSite Brachytherapy	brachytherapy	Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
3-dimensional conformal radiotherapy	3-dimensional conformal radiation therapy	3-dimensional conformal radiotherapy twice daily for 5-10 days.
MammoSite Brachytherapy	adjuvant therapy	Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
3-dimensional conformal radiotherapy	adjuvant therapy	3-dimensional conformal radiotherapy twice daily for 5-10 days.

Primary Outcome Measures

Name	Time	Method
Determination of which patients are best suited for each individual technique of partial breast irradiation	Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates	Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Wound healing and overall complication rate after partial breast irradiation	1 month after RT & Q3mos for one year
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon	1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire	Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr

Trial Locations

Locations (4)

Lake/University Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Westlake Medical Center; 🇺🇸 Cleveland, Ohio, United States