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Proton vs Photon IMRT Toxicity in Breast Cancer (NCT07537712)

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Summary

NIH registered clinical trial NCT07537712, an observational study comparing acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients. The study will follow eligible patients for at least one year to assess incidence and severity of toxicities affecting the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues, as well as patient-reported outcomes, cosmetic outcomes, and quality of life. The trial has an estimated completion date of April 17, 2026.

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What changed

NIH registered a new observational clinical trial on ClinicalTrials.gov under NCT07537712, titled 'Proton vs Photon IMRT Toxicity in Breast Cancer.' The study is an observational, non-interventional trial comparing intensity-modulated proton therapy (IMPT) against intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with primary endpoints including acute and late toxicities to critical organs and patient-reported outcomes. Estimated completion date is April 17, 2026.

For healthcare providers, clinical investigators, and medical device manufacturers involved in radiotherapy, this trial registration signals ongoing comparative effectiveness research between proton and photon-based radiation therapies for breast cancer, which may inform future clinical practice patterns and technology adoption decisions. The study's focus on cardiac, pulmonary, and lymphatic toxicities is relevant to radiotherapy safety monitoring and quality assurance programs.

Archived snapshot

Apr 17, 2026

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Proton vs Photon IMRT Toxicity in Breast Cancer

Observational NCT07537712 Kind: OBSERVATIONAL Apr 17, 2026

Abstract

This study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.

Conditions: Breast Cancer

Interventions: Intensity-modulated photon radiotherapy (IMRT/VMAT), Intensity-modulated proton therapy (IMPT)

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537712

Who this affects

Applies to
Healthcare providers Medical device makers Patients
Industry sector
3345 Medical Device Manufacturing
Activity scope
Comparative effectiveness research Oncology radiation therapy Clinical trial registration
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Public Health

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