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Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer — NOVEMBER  

Stage II Breast Cancer Clinical Trial

Official title:
NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer

Clinical Trial Summary

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03345420
Study type Interventional
Source University of Utah
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 12, 2017
Completion date September 3, 2025
View Details
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