RecruitingPhase 3NCT05856773

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)


Sponsor

Proton Collaborative Group

Enrollment

276 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation schedules — the standard daily dosing over many weeks versus a shorter, higher-dose-per-session approach (called hypofractionation) — for breast cancer patients who need radiation to both the breast/chest wall and the surrounding lymph nodes after surgery. It uses an advanced form of proton therapy. **You may be eligible if...** - You have been diagnosed with stage I, II, or III breast cancer - You have had surgery (either breast-conserving surgery or mastectomy) and your doctors have recommended radiation to the breast or chest wall plus the surrounding lymph nodes - You have a negative scan showing no distant spread of cancer - You are able to start radiation within 12 weeks of your last surgery or chemotherapy - You are not pregnant **You may NOT be eligible if...** - You have active connective tissue disease involving the skin (like scleroderma or active lupus) - You have already had radiation to the chest area - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton Therapy

Pencil Beam Scanning (PBS)


Locations(7)

Mayo Clinic

Scottsdale, Arizona, United States

California Protons Cancer Therapy Center

San Diego, California, United States

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

New York Proton Center

New York, New York, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05856773


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