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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:3/8/2019
Start Date:February 2016
End Date:November 2030
Contact:Justin Bekelman, MD
Email:bekelman@uphs.upenn.edu
Phone:215-662-7266

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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.

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.

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.
We found this trial at
30
sites
Saint Louis, Missouri 63110
Phone: 314-747-7236
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-778-3473
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-7250
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24 Sturtevant St
Orlando, Florida 32806
Phone: 321-841-7413
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-598-4100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-2328
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, Maryland 21218
(410) 516-8000
Phone: 305-588-4511
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Chicago, Illinois 60190
Phone: 630-352-5350
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-584-7698
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, Ohio 44194
Phone: 216-896-1755
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Dallas, Texas 75390
Phone: 214-645-8556
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Danvers, Massachusetts 01923
Phone: 978-882-6060
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Flint, Michigan 48532
Phone: 810-342-3800
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Gainesville, Florida 32608
Phone: 904-588-1800
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4300 Londonderry Road
Harrisburg, Pennsylvania 17109
Phone: 717-724-6760
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Houston, Texas 77030
Phone: 713-792-2121
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Irving, Texas 75063
Phone: 469-513-5500
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Jacksonville, Florida 32206
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Knoxville, Tennessee 37909
Phone: 865-437-5252
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Miami, Florida 33176
Phone: 786-527-8044
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New Brunswick, New Jersey 08903
Phone: 732-253-3939
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Oklahoma City, Oklahoma 73142
Phone: 888-847-2640
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Gary Freedman, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Phoenix, Arizona 85054
Phone: 480-301-8000
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Royal Oak, Michigan
Phone: 248-551-7038
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San Diego, California 92093
Phone: 858-246-0500
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Shreveport, Louisiana 71105
Phone: 318-212-4639
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Somerset, New Jersey 08873
Phone: 212-639-5219
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Somerset, New Jersey 08873
Principal Investigator: Henry Tsai, MD
Phone: 732-357-2600
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