The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients

Official Summary

The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 100 participants

Primary Outcomes

• Change in Global Longitudinal Strain (GLS) (Baseline, 6 Months)

Secondary Outcomes

• Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography (Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment)
• Radiation-induced Lung Parenchymal Changes Using CT Imaging (Baseline, 3,6,12, months post treatment)
• Incidence of Thyroid Dysfunction (Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment)
• Incidence of Ipsilateral Arm Lymphedema (Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment)
• Severity of Ipsilateral Arm Lymphedema (Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment)

Eligibility Criteria

Inclusion Criteria:

* Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341)
* Ability to understand and the willingness to sign a study-specific written informed consent document

Exclusion Criteria:

* There are no exclusion criteria.

Trial Locations

• Massachusetts General Hospital, Boston, Massachusetts, United States

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