Spots Global Cancer Trial Database for Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial