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

NCT ID: NCT02603341

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-06
• Study Completion Date: 2036-11-30

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.

Detailed Description

Because no one knows which radiation treatment is best, if you decide to take part in this study, you will be randomly assigned to 1 of 2 treatment groups, and then you will begin radiation treatment according to usual medical practice. Randomly assigning you to a group helps makes sure that each group has a similar mix of patients and makes the study better - and is only done when doctors are not sure whether one treatment is better than the other. You have an equal chance of getting into either treatment group, like a coin flip. Both you and your doctor will be told which treatment you will get.

No matter which group patients are in, doctors will work very carefully to reduce the radiation to healthy tissues. Both groups will followed for at least 10 years after completing radiation therapy. The results of this study will help decide which radiation is best for future patients with your type of breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photon

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

Group Type: ACTIVE_COMPARATOR

Photon

Intervention Type: RADIATION

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

Proton

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

Group Type: ACTIVE_COMPARATOR

Proton

Intervention Type: RADIATION

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

Interventions

Photon

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

Intervention Type: RADIATION

Proton

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Bonnie Ky, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Shannon MacDonald, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

University of Alabama

Birmingham, Alabama, United States

Mayo Clinic-Arizona

Phoenix, Arizona, United States

UC San Diego

San Diego, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of Miami Sylvester Cancer Center at Coral Gables

Coral Gables, Florida, United States

University of Miami Sylvester Cancer Center - Deerfield

Deerfield Beach, Florida, United States

University of Florida Health

Gainesville, Florida, United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, United States

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Insititute

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern Medicine Proton Center

Chicago, Illinois, United States

Willis Knighton

Shreveport, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mass General/North Shore Cancer Center

Danvers, Massachusetts, United States

McLaren Proton Therapy

Flint, Michigan, United States

William Beaumont

Royal Oak, Michigan, United States

Mayo Clinic-Rochester

Rochester, Minnesota, United States

Washington University, St. Louis

St Louis, Missouri, United States

RWJ University Hospital Hamilton

Hamilton, New Jersey, United States

Cancer Institute of NJ

New Brunswick, New Jersey, United States

ProCure Proton Therapy Center

Somerset, New Jersey, United States

New York Proton Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals, Case Medical Center

Cleveland, Ohio, United States

University Pointe, University of Cincinnati

West Chester, Ohio, United States

Oklahoma University - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Pinnacle Health Cancer Institute

Harrisburg, Pennsylvania, United States

Abramson Cancer Center at Penn Medicine

Philadelphia, Pennsylvania, United States

Chester County Hospital

West Chester, Pennsylvania, United States

Thompson Proton Center

Knoxville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Center for Proton Therapy

Irving, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31619413 (View on PubMed)

Related Links

http://www.radcomp.org

Study website

Other Identifiers

UPCC 19115

Identifier Type: -

Identifier Source: org_study_id