This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 2 for:    NCT02603341
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by University of Pennsylvania
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02603341
First received: November 9, 2015
Last updated: September 1, 2017
Last verified: September 2017
  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 November, 2020, www.radcomp.org.

Condition Intervention
Breast Cancer Radiation: Photon Radiation: Proton

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 1720
Study Start Date: February 2016
Estimated Study Completion Date: November 2030
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02603341

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

  Show 25 Study Locations
Sponsors and Collaborators
University of Pennsylvania
Patient-Centered Outcomes Research Institute
Investigators
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
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02603341     History of Changes
Other Study ID Numbers: UPCC 19115
Study First Received: November 9, 2015
Last Updated: September 1, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 21, 2017