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

Breast Cancer Clinical 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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02603341
• Other study ID #: UPCC 19115
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2036

Study information

• Verified date: April 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 December, 2024, www.radcomp.org.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1238
• Est. completion date: November 2036
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Photon
Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks
• Proton
Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern Medicine Proton Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals, Case Medical Center	Cleveland	Ohio
United States	University of Miami Sylvester Cancer Center at Coral Gables	Coral Gables	Florida
United States	Mass General/North Shore Cancer Center	Danvers	Massachusetts
United States	University of Miami Sylvester Cancer Center - Deerfield	Deerfield Beach	Florida
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	McLaren Proton Therapy	Flint	Michigan
United States	University of Florida Health	Gainesville	Florida
United States	RWJ University Hospital Hamilton	Hamilton	New Jersey
United States	Pinnacle Health Cancer Institute	Harrisburg	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Center for Proton Therapy	Irving	Texas
United States	University of Florida Health Proton Therapy Institute	Jacksonville	Florida
United States	Thompson Proton Center	Knoxville	Tennessee
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Miami Cancer Insititute	Miami	Florida
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	Cancer Institute of NJ	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York Proton Center	New York	New York
United States	Oklahoma University - Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Orlando Health	Orlando	Florida
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic-Arizona	Phoenix	Arizona
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	William Beaumont	Royal Oak	Michigan
United States	Washington University, St. Louis	Saint Louis	Missouri
United States	UC San Diego	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Willis Knighton	Shreveport	Louisiana
United States	ProCure Proton Therapy Center	Somerset	New Jersey
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Chester County Hospital	West Chester	Pennsylvania
United States	University Pointe, University of Cincinnati	West Chester	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 years
Secondary	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)	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	Long Term Survival	To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.	15 years

External Links

•   Study website