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NCT Number: NCT03270072

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Stage II Breast Cancer Stage III Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Global Longitudinal Strain (GLS)

    Time frame: Baseline, 6 Months

    Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS.

Secondary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography

    Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment

    Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction <50%.

  2. Radiation-induced Lung Parenchymal Changes Using CT Imaging

    Time frame: Baseline, 3,6,12, months post treatment

    Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks.

  3. Incidence of Thyroid Dysfunction

    Time frame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment

    Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks.

  4. Incidence of Ipsilateral Arm Lymphedema

    Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment

    Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.

  5. Severity of Ipsilateral Arm Lymphedema

    Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment

    Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.

  6. Ipsilateral Breast/Chest Wall Cosmesis

    Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment

    Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Sep 1, 2017
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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