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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603341
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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 August, 2022, www.radcomp.org.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Photon Radiation: Proton Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Study Start Date : February 2016
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : November 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Photon
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
Radiation: Photon
Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks

Active Comparator: Proton
Proton 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




Primary Outcome Measures :
  1. Effectiveness of proton therapy vs. photon therapy [ Time Frame: 10 years ]
    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).


Secondary Outcome Measures :
  1. Disease Control [ Time Frame: 5 years ]
    Compare the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence, defined as the first reported breast cancer recurrence of any type (local-regional or distant or cancer-specific mortality)

  2. Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL) [ Time Frame: 5 years ]
    Compare the effectiveness of proton vs. photon therapy in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (HRQOL) (anxiety, social roles, financial toxicity, general satisfaction) and adverse events.

  3. Radiation Dose and Quality of Life and Cardiac Toxicity [ Time Frame: 5 years ]
    Develop predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and major cardiovascular events and quality of life outcomes.

  4. Long Term Survival [ Time Frame: 15 years ]
    To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603341


Contacts
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Contact: Justin Bekelman, MD 215-662-7266 bekelman@uphs.upenn.edu
Contact: Hien Lu 215-662-6694 hien.lu@pennmedicine.upenn.edu

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Drexell H. Boggs, MD    205-934-5670    dboggs@uabmc.edu   
United States, Arizona
Mayo Clinic-Arizona Active, not recruiting
Phoenix, Arizona, United States, 85054
United States, California
UC San Diego Recruiting
San Diego, California, United States, 92121
Contact: James Urbanic, MD    858-246-0500    jurbanic@ucsd.edu   
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sonali Rudra, MD    202-444-3320    Sonali.Rudra@gunet.georgetown.edu   
United States, Florida
University of Miami Sylvester Cancer Center at Coral Gables Recruiting
Coral Gables, Florida, United States, 33146
Contact: Christiane Takita, MD, MBA    305-243-4337    ctakita@med.miami.edu   
University of Miami Sylvester Cancer Center - Deerfield Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Christiane Takita, MD, MBA    305-243-4337    ctakita@med.miami.edu   
University of Florida Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Julie Bradley, MD    904-588-1800    jbradley@floridaproton.org   
University of Florida Health Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Julie Bradley, MD    904-588-1800    jbradley@floridaproton.org   
Mayo Clinic Florida Withdrawn
Jacksonville, Florida, United States, 32224
University of Miami Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Christiane Takita, MD, MBA    305-243-4337    ctakita@med.miami.edu   
Miami Cancer Insititute Active, not recruiting
Miami, Florida, United States, 33176
Orlando Health Active, not recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sagar Patel, MD    404-778-1900    sagar.patel@emory.edu   
United States, Illinois
Northwestern Medicine Proton Center Recruiting
Chicago, Illinois, United States, 60190
Contact: Arpi Thukral, MD    630-821-6400    athukral@chicagocancer.org   
United States, Louisiana
Willis Knighton Active, not recruiting
Shreveport, Louisiana, United States, 71103
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark Mishra, MD    410-328-2328    mmishra@umm.edu   
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jean Wright, MD    305-588-4511    jeanwright@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Shannon MacDonald, MD    617-643-7250    SMACDONALD@mgh.harvard.edu   
Mass General/North Shore Cancer Center Recruiting
Danvers, Massachusetts, United States, 01923
Contact: James McIntyre, MD    978-882-6060    jfmcintyre@mgh.harvard.edu   
United States, Michigan
McLaren Proton Therapy Active, not recruiting
Flint, Michigan, United States, 48532
William Beaumont Terminated
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic-Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Mutter, MD    507-284-2511    mutter.robert@mayo.edu   
United States, Missouri
Washington University, St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
RWJ University Hospital Hamilton Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Bruce Haffty, MD    732-253-3939    hafftyb@cinj.rutgers.edu   
Cancer Institute of NJ Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Bruce Haffty, MD    732-253-3939    hafftyb@cinj.rutgers.edu   
ProCure Proton Therapy Center Active, not recruiting
Somerset, New Jersey, United States, 07728
United States, New York
New York Proton Center Recruiting
New York, New York, United States, 10035
Contact: Isabelle Choi, MD    646-968-9031    ichoi@nyproton.com   
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Teresa Meier, MD    513-584-7698    meierta@ucmail.uc.edu   
University Hospitals, Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Janice Lyons, MD    216-896-1755    janice.lyons@uhhospitals.org   
University Pointe, University of Cincinnati Recruiting
West Chester, Ohio, United States, 45069
Contact: Teresa Meier, MD    513-475-7777    meierta@ucmail.uc.edu   
United States, Oklahoma
Oklahoma University - Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ozer Algan, MD    405-271-5641    Ozer-algan@ouhsc.edu   
Oklahoma City Procure Withdrawn
Oklahoma City, Oklahoma, United States, 73142
United States, Pennsylvania
Pinnacle Health Cancer Institute Active, not recruiting
Harrisburg, Pennsylvania, United States, 17109
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gary Freedman, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Gary Freedman, MD         
Chester County Hospital Recruiting
West Chester, Pennsylvania, United States, 19380
Contact: Andre Konski, MD, MBA    610-431-5530    andre.konski@uphs.upenn.edu   
United States, Tennessee
Provision Center for Proton Therapy Active, not recruiting
Knoxville, Tennessee, United States, 37909
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen Hoffman, MD    713-792-2121    KHoffman1@mdanderson.org   
Texas Center for Proton Therapy Active, not recruiting
Irving, Texas, United States, 75063
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98133
Contact: Waylene Wang, MD    206-368-5808    waylene@uw.edu   
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Waylene Wang, MD    206-598-4100    waylene@uw.edu   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Justin Bekelman, MD Abramson Cancer Center of the University of Pennsylvania
Study Chair: Oren Cahlon, MD Memorial Sloan Kettering Cancer Center
Study Chair: Shannon MacDonald, MD Massachusetts General Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02603341    
Other Study ID Numbers: UPCC 19115
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases