Clinical trial NCT02603341: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-11-11
Enrollment: 1238
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 December, 2024, 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.

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.

Primary outcomes:
measure: Effectiveness of proton therapy vs. photon therapy
timeFrame: 10 years
Secondary outcomes:
measure: Disease Control
timeFrame: 5 years
measure: Patient-reported Body Image and Function, Fatigue and Other Measures of Health-related Quality of Life (HRQOL)
timeFrame: 5 years
measure: Radiation Dose and Quality of Life and Cardiac Toxicity
timeFrame: 5 years
measure: Long Term Survival
timeFrame: 15 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic-Arizona
state: Arizona
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Coral Gables
country: United States
facility: University of Miami Sylvester Cancer Center at Coral Gables
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami Sylvester Cancer Center - Deerfield
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Cancer Center
state: Florida
city: Miami
country: United States
facility: Miami Cancer Insititute
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine Proton Center
state: Illinois
city: Shreveport
country: United States
facility: Willis Knighton
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Danvers
country: United States
facility: Mass General/North Shore Cancer Center
state: Massachusetts
city: Flint
country: United States
facility: McLaren Proton Therapy
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: St. Louis
country: United States
facility: Washington University, St. Louis
state: Missouri
city: Hamilton Township
country: United States
facility: RWJ University Hospital Hamilton
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of NJ
state: New Jersey
city: Somerset
country: United States
facility: ProCure Proton Therapy Center
state: New Jersey
city: New York
country: United States
facility: New York Proton Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals, Case Medical Center
state: Ohio
city: West Chester
country: United States
facility: University Pointe, University of Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University - Stephenson Cancer Center
state: Oklahoma
city: Harrisburg
country: United States
facility: Pinnacle Health Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center at Penn Medicine
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Proton Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Texas Center for Proton Therapy
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Alexander Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abramson Cancer Center at Penn Medicine
name: Bonnie Ky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Shannon MacDonald, MD
role: STUDY_CHAIR
References:
citation: Bekelman JE, Lu H, Pugh S, Baker K, Berg CD, Berrington de Gonzalez A, 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.