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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

NCT02603341 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1238

Last updated 2025-11-06

No results posted yet for this study

Summary

A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of December, 2024, www.radcomp.org.

Conditions

Interventions

RADIATION

Photon

Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks

RADIATION

Proton

Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Alexander Lin, MD · Abramson Cancer Center at Penn Medicine

  • Bonnie Ky, MD · Abramson Cancer Center at Penn Medicine

  • Shannon MacDonald, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-06
Primary Completion
2036-11-30
Completion
2036-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603341 on ClinicalTrials.gov