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

NCT03270072 | Active Not Recruiting

• 1 other identifier: 17-031
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer Stage II; Breast Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Photon Therapy

The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy.

Proton Therapy

The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled at Massachusetts General Hospital on the 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel Jimenez, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: September 1, 2017
• Study Start: October 26, 2017
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)