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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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photon
Proton
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of AlabamaRecruiting
  • Mayo Clinic-Arizona
  • UC San DiegoRecruiting
  • Georgetown University Medical Center
  • University of Miami Sylvester Cancer Center at Coral GablesRecruiting
  • University of Miami Sylvester Cancer Center - DeerfieldRecruiting
  • University of Florida HealthRecruiting
  • University of Florida Health Proton Therapy Institute
  • Mayo Clinic Florida
  • University of Miami Sylvester Cancer CenterRecruiting
  • Miami Cancer InsitituteRecruiting
  • Orlando Health
  • Emory University
  • Northwestern Medicine Proton CenterRecruiting
  • Willis Knighton
  • University of MarylandRecruiting
  • Johns HopkinsRecruiting
  • Massachusetts General HospitalRecruiting
  • Mass General/North Shore Cancer CenterRecruiting
  • McLaren Proton Therapy
  • William Beaumont
  • Mayo Clinic-RochesterRecruiting
  • Washington University, St. Louis
  • RWJ University Hospital HamiltonRecruiting
  • Cancer Institute of NJRecruiting
  • ProCure Proton Therapy Center
  • New York Proton CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of CincinnatiRecruiting
  • University Hospitals, Case Medical Center
  • University Pointe, University of CincinnatiRecruiting
  • Oklahoma University - Stephenson Cancer CenterRecruiting
  • Oklahoma City Procure
  • Pinnacle Health Cancer Institute
  • Lancaster General HospitalRecruiting
  • Abramson Cancer Center of the University of PennsylvaniaRecruiting
  • Chester County HospitalRecruiting
  • Thompson Proton Center
  • MD Anderson Cancer CenterRecruiting
  • Texas Center for Proton Therapy
  • Inova Schar Cancer InstituteRecruiting
  • Seattle Cancer Care AllianceRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Photon

Proton

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disease Control
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)
Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL)
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.
Radiation Dose and Quality of Life and Cardiac Toxicity
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.
Long Term Survival
To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

Full Information

First Posted
November 9, 2015
Last Updated
September 20, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02603341
Brief Title
Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
November 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photon
Arm Type
Active Comparator
Arm Description
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
Arm Title
Proton
Arm Type
Active Comparator
Arm Description
Proton therapy: once a day, 5 days a week, for 5 to 7 weeks
Intervention Type
Radiation
Intervention Name(s)
Photon
Intervention Description
Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks
Intervention Type
Radiation
Intervention Name(s)
Proton
Intervention Description
Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks
Primary Outcome Measure Information:
Title
Effectiveness of proton therapy vs. photon therapy
Description
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).
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Disease Control
Description
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)
Time Frame
5 years
Title
Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL)
Description
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.
Time Frame
5 years
Title
Radiation Dose and Quality of Life and Cardiac Toxicity
Description
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.
Time Frame
5 years
Title
Long Term Survival
Description
To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.
Time Frame
15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Bekelman, MD
Phone
215-662-7266
Email
bekelman@uphs.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hien Lu
Phone
215-662-6694
Email
hien.lu@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Bekelman, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oren Cahlon, MD
Organizational Affiliation
NYU Langone
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drexell H. Boggs, MD
Phone
205-934-5670
Email
dboggs@uabmc.edu
Facility Name
Mayo Clinic-Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Urbanic, MD
Phone
858-246-0500
Email
jurbanic@ucsd.edu
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Miami Sylvester Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Takita, MD, MBA
Phone
305-243-4337
Email
ctakita@med.miami.edu
Facility Name
University of Miami Sylvester Cancer Center - Deerfield
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiane Takita, MD, MBA
Phone
305-243-4337
Email
ctakita@med.miami.edu
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Bradley, MD
Phone
904-588-1800
Email
jbradley@floridaproton.org
Facility Name
University of Florida Health Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Miami Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Takita, MD, MBA
Phone
305-243-4337
Email
ctakita@med.miami.edu
Facility Name
Miami Cancer Insititute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcio Fagundes, MD
Phone
786-527-8044
Email
Marciof@baptisthealth.net
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwestern Medicine Proton Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arpi Thukral, MD
Phone
630-821-6400
Email
athukral@chicagocancer.org
Facility Name
Willis Knighton
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-2328
Email
mmishra@umm.edu
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Wright, MD
Phone
305-588-4511
Email
jeanwright@jhmi.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald, MD
Phone
617-643-7250
Email
SMACDONALD@mgh.harvard.edu
Facility Name
Mass General/North Shore Cancer Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James McIntyre, MD
Phone
978-882-6060
Email
jfmcintyre@mgh.harvard.edu
Facility Name
McLaren Proton Therapy
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
William Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Terminated
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Mutter, MD
Phone
507-284-2511
Email
mutter.robert@mayo.edu
Facility Name
Washington University, St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
RWJ University Hospital Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Haffty, MD
Phone
732-253-3939
Email
hafftyb@cinj.rutgers.edu
Facility Name
Cancer Institute of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Haffty, MD
Phone
732-253-3939
Email
hafftyb@cinj.rutgers.edu
Facility Name
ProCure Proton Therapy Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Proton Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Choi, MD
Phone
646-968-9031
Email
ichoi@nyproton.com
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lior Braunstein, MD
Phone
201-775-7446
Email
Braunstl@mskcc.org
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Meier, MD
Phone
513-584-7698
Email
meierta@ucmail.uc.edu
Facility Name
University Hospitals, Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Pointe, University of Cincinnati
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Meier, MD
Phone
513-475-7777
Email
meierta@ucmail.uc.edu
Facility Name
Oklahoma University - Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozer Algan, MD
Phone
405-271-5641
Email
Ozer-algan@ouhsc.edu
Facility Name
Oklahoma City Procure
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pinnacle Health Cancer Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Boimel, MD
Phone
717-544-3113
Email
Pamela.Boimel@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Susan Tollett, BSN
Phone
717-544-0511
Email
susan.tollett@pennmedicine.upenn.edu
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Freedman, MD
Phone
855-216-0098
Email
PennCancerTrials@emergingmed.com
First Name & Middle Initial & Last Name & Degree
Gary Freedman, MD
Facility Name
Chester County Hospital
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Konski, MD, MBA
Phone
610-431-5530
Email
andre.konski@uphs.upenn.edu
Facility Name
Thompson Proton Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Hoffman, MD
Phone
713-792-2121
Email
KHoffman1@mdanderson.org
Facility Name
Texas Center for Proton Therapy
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Chawla, MD
Phone
571-472-4724
Email
Ashish.Chawla@inova.org
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waylene Wang, MD
Phone
206-368-5808
Email
waylene@uw.edu
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waylene Wang, MD
Phone
206-598-4100
Email
waylene@uw.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
31619413
Citation
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.
Results Reference
derived
Links:
URL
http://www.radcomp.org
Description
Study website

Learn more about this trial

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

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