Clinical Trials /

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

NCT02603341

Description:

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.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: UPCC 19115
  • NCT ID: NCT02603341

Conditions

  • Breast Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
PhotonActive ComparatorPhoton therapy: once a day, 5 days a week, for 5 to 7 weeks
    ProtonActive ComparatorProton therapy: once a day, 5 days a week, for 5 to 7 weeks

      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.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:21 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Effectiveness of proton therapy vs. photon therapy
      Time Frame:10 years
      Safety Issue:
      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).

      Secondary Outcome Measures

      Measure:Disease Control
      Time Frame:5 years
      Safety Issue:
      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)
      Measure:Quality of Life
      Time Frame:5 years
      Safety Issue:
      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.
      Measure:Radiation Dose and Quality of Life and Cardiac Toxicity
      Time Frame:5 years
      Safety Issue:
      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.
      Measure:Long Term Survival
      Time Frame:15 years
      Safety Issue:
      Description:To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

      Last Updated

      February 2, 2021