Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ductal Breast Carcinoma In Situ
- Invasive Breast Carcinoma
- Stage 0 Breast Cancer
- Stage I Breast Cancer
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage II Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation. SECONDARY OBJECTIVES: I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation. II. To evaluate the ...
PRIMARY OBJECTIVES: I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation. SECONDARY OBJECTIVES: I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation. II. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. III. To evaluate the local and local regional recurrence rate. IV. To compare the direct and indirect patient costs for radiation therapy compared to historical controls as well as quality adjusted life years, utilizing the Breast-Q Patient Reported Outcomes (PROs) and the EQ-5D. OUTLINE: Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks. After completion of study treatment, patients are followed up at 2-8 weeks, 6 months, and annually for 3 years.
Tracking Information
- NCT #
- NCT03345420
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthew Poppe Huntsman Cancer Institute/ University of Utah