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

Breast Cancer Stage II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270072
• Other study ID #: 17-031
• Status: Recruiting
• Start date: October 26, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Rachel Jimenez, MD
• Phone: 617-726-7559
• Email: RBJIMENEZ[@]PARTNERS.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Longitudinal Strain (GLS)	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.	Baseline, 6 Months
Secondary	Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography	Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction <50%.	Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Secondary	Radiation-induced Lung Parenchymal Changes Using CT Imaging	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.	Baseline, 3,6,12, months post treatment
Secondary	Incidence of Thyroid Dysfunction	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.	Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
Secondary	Incidence of Ipsilateral Arm Lymphedema	Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.	Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Secondary	Severity of Ipsilateral Arm Lymphedema	Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.	Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Secondary	Ipsilateral Breast/Chest Wall Cosmesis	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.	Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment