Spots Global Cancer Trial Database for Intraoperative Radiation Therapy in Early Stage Breast Cancer
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Trial Identification
Brief Title: Intraoperative Radiation Therapy in Early Stage Breast Cancer
Official Title: Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
Study ID: NCT02266602
Conditions
Interventions
Study Description
Brief Summary: Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Detailed Description: The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of: * Local recurrence in early stage breast cancer patients treated with IORT. * Toxicity associated with IORT. * Long-term disease-specific and overall survival * Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT. * Quality of life in patients treated with IORT. * Health care costs associated with IORT.
Keywords
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Virginia Mason Medical Center, Seattle, Washington, United States
Contact Details
Name: Janie Grumley, MD
Affiliation: Virginia Mason Medical Center
Role: PRINCIPAL_INVESTIGATOR
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