NCT02958774

Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

Detailed description

Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. Secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily

Timeline

• Start date: 2017-10-23
• Primary completion: 2024-01-06
• Completion: 2029-03-01
• First posted: 2016-11-08
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study