NCT05856773

Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy

Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Proton Collaborative Group · Network
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.

Detailed description

This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Proton Therapy	Pencil Beam Scanning (PBS)

Timeline

• Start date: 2024-03-21
• Primary completion: 2038-02-01
• Completion: 2041-02-01
• First posted: 2023-05-12
• Last updated: 2025-09-09

Locations

7 sites across 1 country: United States