Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
1 other identifier
interventional
1,238
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Apr 2016
Longer than P75 for not_applicable breast-cancer
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2036
November 6, 2025
November 1, 2025
20.6 years
November 9, 2015
November 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of proton therapy vs. photon therapy
Compare the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).
10 years
Secondary Outcomes (4)
Disease Control
5 years
Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL)
5 years
Radiation Dose and Quality of Life and Cardiac Toxicity
5 years
Long Term Survival
15 years
Study Arms (2)
Photon
ACTIVE COMPARATORPhoton therapy: once a day, 5 days a week, for 5 to 7 weeks
Proton
ACTIVE COMPARATORProton therapy: once a day, 5 days a week, for 5 to 7 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
- For patients who have undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed.
- For patients who have undergone lumpectomy, there are no breast size limitations.
- Patients with non-metastatic breast cancer are eligible. This includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis. For patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible.
- Bilateral breast cancer is permitted. Patients with bilateral breast cancer will be stratified as left-sided.
- Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
- Must have a pertinent history/physical examination within 90 days prior to registration.
- Age ≥ 21 years
- ECOG Performance Status 0 - 2 (asymptomatic to symptomatic but capable of self-care) within 90 days prior to randomization.
- Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.
- Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing is not required for eligibility for this protocol.
- The patient must provide study-specific informed consent prior to study entry.
You may not qualify if:
- Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution.
- Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible.
- Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
- Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma.
- Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of Alabama
Birmingham, Alabama, 35233, United States
Mayo Clinic-Arizona
Phoenix, Arizona, 85054, United States
UC San Diego
San Diego, California, 92121, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
University of Miami Sylvester Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
University of Miami Sylvester Cancer Center - Deerfield
Deerfield Beach, Florida, 33442, United States
University of Florida Health
Gainesville, Florida, 32610, United States
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206, United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Insititute
Miami, Florida, 33176, United States
Orlando Health
Orlando, Florida, 32806, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern Medicine Proton Center
Chicago, Illinois, 60190, United States
Willis Knighton
Shreveport, Louisiana, 71103, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
McLaren Proton Therapy
Flint, Michigan, 48532, United States
William Beaumont
Royal Oak, Michigan, 48073, United States
Mayo Clinic-Rochester
Rochester, Minnesota, 55905, United States
Washington University, St. Louis
St Louis, Missouri, 63110, United States
RWJ University Hospital Hamilton
Hamilton, New Jersey, 08690, United States
Cancer Institute of NJ
New Brunswick, New Jersey, 08903, United States
ProCure Proton Therapy Center
Somerset, New Jersey, 07728, United States
New York Proton Center
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals, Case Medical Center
Cleveland, Ohio, 44106, United States
University Pointe, University of Cincinnati
West Chester, Ohio, 45069, United States
Oklahoma University - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Pinnacle Health Cancer Institute
Harrisburg, Pennsylvania, 17109, United States
Abramson Cancer Center at Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Thompson Proton Center
Knoxville, Tennessee, 37909, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Center for Proton Therapy
Irving, Texas, 75063, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98133, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Bekelman JE, Lu H, Pugh S, Baker K, Berg CD, Berrington de Gonzalez A, Braunstein LZ, Bosch W, Chauhan C, Ellenberg S, Fang LC, Freedman GM, Hahn EA, Haffty BG, Khan AJ, Jimenez RB, Kesslering C, Ky B, Lee C, Lu HM, Mishra MV, Mullins CD, Mutter RW, Nagda S, Pankuch M, Powell SN, Prior FW, Schupak K, Taghian AG, Wilkinson JB, MacDonald SM, Cahlon O; RadComp (Radiotherapy Comparative Effectiveness Consortium). Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. BMJ Open. 2019 Oct 15;9(10):e025556. doi: 10.1136/bmjopen-2018-025556.
PMID: 31619413DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Lin, MD
Abramson Cancer Center at Penn Medicine
- PRINCIPAL INVESTIGATOR
Bonnie Ky, MD
Abramson Cancer Center at Penn Medicine
- STUDY CHAIR
Shannon MacDonald, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 11, 2015
Study Start
April 6, 2016
Primary Completion (Estimated)
November 1, 2036
Study Completion (Estimated)
November 1, 2036
Last Updated
November 6, 2025
Record last verified: 2025-11