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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT02603341
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,278
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Photon
  • Radiation: Proton
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Nov 1, 2032

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Effectiveness of proton therapy vs. photon therapy [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 [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. Quality of Life [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 [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 [15 years]

    To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Alabama Birmingham Alabama United States 35233
2 Mayo Clinic-Arizona Phoenix Arizona United States 85054
3 UC San Diego San Diego California United States 92121
4 Georgetown University Medical Center Washington District of Columbia United States 20007
5 University of Miami Sylvester Cancer Center at Coral Gables Coral Gables Florida United States 33146
6 University of Miami Sylvester Cancer Center - Deerfield Deerfield Beach Florida United States 33442
7 University of Florida Health Gainesville Florida United States 32610
8 University of Florida Health Proton Therapy Institute Jacksonville Florida United States 32206
9 Mayo Clinic Florida Jacksonville Florida United States 32224
10 University of Miami Sylvester Cancer Center Miami Florida United States 33136
11 Miami Cancer Insititute Miami Florida United States 33176
12 Orlando Health Orlando Florida United States 32806
13 Emory University Atlanta Georgia United States 30322
14 Northwestern Medicine Proton Center Chicago Illinois United States 60190
15 Willis Knighton Shreveport Louisiana United States 71103
16 University of Maryland Baltimore Maryland United States 21201
17 Johns Hopkins Baltimore Maryland United States 21287
18 Massachusetts General Hospital Boston Massachusetts United States 02114
19 Mass General/North Shore Cancer Center Danvers Massachusetts United States 01923
20 McLaren Proton Therapy Flint Michigan United States 48532
21 William Beaumont Royal Oak Michigan United States 48073
22 Mayo Clinic-Rochester Rochester Minnesota United States 55905
23 Washington University, St. Louis Saint Louis Missouri United States 63110
24 RWJ University Hospital Hamilton Hamilton New Jersey United States 08690
25 Cancer Institute of NJ New Brunswick New Jersey United States 08903
26 ProCure Proton Therapy Center Somerset New Jersey United States 07728
27 New York Proton Center New York New York United States 10035
28 Memorial Sloan Kettering Cancer Center New York New York United States 10065
29 University of Cincinnati Cincinnati Ohio United States 45267
30 University Hospitals, Case Medical Center Cleveland Ohio United States 44106
31 University Pointe, University of Cincinnati West Chester Ohio United States 45069
32 Oklahoma University - Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
33 Oklahoma City Procure Oklahoma City Oklahoma United States 73142
34 Pinnacle Health Cancer Institute Harrisburg Pennsylvania United States 17109
35 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
36 Chester County Hospital West Chester Pennsylvania United States 19380
37 Provision Center for Proton Therapy Knoxville Tennessee United States 37909
38 MD Anderson Cancer Center Houston Texas United States 77030
39 Texas Center for Proton Therapy Irving Texas United States 75063
40 Seattle Cancer Care Alliance Seattle Washington United States 98133
41 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania
  • Patient-Centered Outcomes Research Institute

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02603341
Other Study ID Numbers:
  • UPCC 19115
First Posted:
Nov 11, 2015
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022