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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

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ClinicalTrials.gov Identifier: NCT02603341
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 9, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Number of Adverse Events [ Time Frame: 5 years ]
Change History Complete list of historical versions of study NCT02603341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
  • 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)
  • Quality of Life [ 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.
  • 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.
  • Long Term Survival [ Time Frame: 15 years ]
    To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Official Title  ICMJE Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Photon
    Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
    Intervention: Radiation: Photon
  • Active Comparator: Proton
    Proton therapy: once a day, 5 days a week, for 5 to 7 weeks
    Intervention: Radiation: Proton
Publications * Bekelman JE, Lu H, Pugh S, Baker K, Berg CD, de Gonzalez AB, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
1278
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
135
Estimated Study Completion Date  ICMJE November 2032
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Justin Bekelman, MD 215-662-7266 bekelman@uphs.upenn.edu
Contact: Hien Lu 215-662-6694 hien.lu@uphs.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603341
Other Study ID Numbers  ICMJE UPCC 19115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Justin Bekelman, MD Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Oren Cahlon, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Shannon McDonald, MD Massacusetts General Hospital
PRS Account University of Pennsylvania
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP