Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Proton Collaborative Group
Study ID
NCT01766297
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proton Radiotherapy — RADIATION

Study Details

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Key Dates

Start date
Feb 28, 2013
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2035

Study Design

Enrollment
132 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton Radiotherapy
    Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose

Primary Outcome Measure

To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor. [ Time Frame: At 3 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Karla Shields Morales
[email protected]
855-776-0015 (toll free)
Carlos Vargas, MD (PRINCIPAL_INVESTIGATOR)
California Protons Cancer Therapy CenterSan DiegoCalifornia92121
Alexandra Crawford, MPH
[email protected]
858-549-7431
James Urbanic, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Medicine Chicago Proton CenterWarrenvilleIllinois60555
Don Smith, MS, CCRC
[email protected]
630-933-7820
Arpi Thukral, MD (PRINCIPAL_INVESTIGATOR)
Maryland Proton Treatment CenterBaltimoreMaryland21201
Caitlin Eggleston
[email protected]
410-328-7586
Elizabeth Nichols, MD (PRINCIPAL_INVESTIGATOR)
McLaren Proton Therapy CenterFlintMichigan48532
Bradley Olsen
[email protected]
313-576-9730
Brian Yeh, MD (PRINCIPAL_INVESTIGATOR)
New York Proton CenterNew YorkNew York10035
Ryan Holder
[email protected]
646-968-9055
Isabelle Choi, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Proton CenterOklahoma CityOklahoma73142
Angela Beebe
[email protected]
405-773-6708
John Chang, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Sangeetha Moturi
[email protected]
571-472-0343
Ashish Chawla, MD (PRINCIPAL_INVESTIGATOR)
Hampton University Proton Therapy InstituteHamptonVirginia23666
Donna Sternberg, RN, BSN, OCN
[email protected]
757-251-6839
Christopher Sinesi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Breast cancer
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OncologyBreast oncologyWomen's health
By research site
Mayo Clinic· Scottsdale, AZCalifornia Protons Cancer Therapy Center· San Diego, CANorthwestern Medicine Chicago Proton Center· Warrenville, ILMaryland Proton Treatment Center· Baltimore, MDMcLaren Proton Therapy Center· Flint, MINew York Proton Center· New York, NY

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