NCT00527293

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

Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy	If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
RADIATION	3-dimensional conformal radiation therapy	3-dimensional conformal radiotherapy twice daily for 5-10 days.
RADIATION	brachytherapy	Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-10-01
• Completion: 2015-02-01
• First posted: 2007-09-10
• Last updated: 2015-08-25

Locations

4 sites across 1 country: United States