NCT03324802

Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. 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 determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost. SECONDARY OBJECTIVES: I. To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control, invasive disease-free survival and overall survival. TERTIARY OBJECTIVES: I. To evaluate fatigue, and other patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with fair and poor cosmetic outcomes or unplanned surgical intervention. III. To evaluate the costs and comparative effectiveness of treatment. IV. Compare the use of photon therapy with spot scanning proton therapy in two different hypo-fractionated whole breast schemas. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo radiation therapy in 15 daily fractions for 10 days. ARM II: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days. After completion of study treatment, patients are followed up to 5 years.

Conditions

• Stage I Breast Cancer AJCC v7
• Stage IA Breast Cancer AJCC v7
• Stage IB Breast Cancer AJCC v7
• Stage II Breast Cancer AJCC v6 and v7
• Stage IIA Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7
• Stage IIIA Breast Cancer AJCC v7

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Radiation Therapy	hypofractionated radiation therapy

Timeline

• Start date: 2018-02-07
• Primary completion: 2022-01-31
• Completion: 2023-08-28
• First posted: 2017-10-30
• Last updated: 2024-05-02
• Results posted: 2023-06-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study