Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Proton Collaborative Group
Study ID
NCT05856773
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Proton Therapy — RADIATION
    Pencil Beam Scanning (PBS)

Study Details

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.

Key Dates

Start date
Mar 21, 2024
Status verified
May 2025
Primary completion
Feb 28, 2038
Completion
Feb 28, 2041

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - Standard Fractionation
    50-50.4 Gy (RBE) in 25-28 daily fractions of 1.8-2.0 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE) \*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*
  • Other: Arm B - Hypofractionation
    40.05 Gy (RBE) in 15 daily fractions of 2.67 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE) \*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*

Primary Outcome Measure

To determine if the rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated PBS proton therapy is non-inferior to conventionally-fractionated proton radiotherapy [ Time Frame: 2 years after radiation therapy ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
June Leonard
[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
Iain MacEwan, MD (PRINCIPAL_INVESTIGATOR)
University of Florida Proton Therapy InstituteJacksonvilleFlorida32206
Robin Cacchio
[email protected]
904-588-1460
Julie Bradley, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer InstituteMiamiFlorida33176
Alex Kudryashev
[email protected]
786-596-2000
Joseph Panoff, MD (PRINCIPAL_INVESTIGATOR)
Emory Proton Therapy CenterAtlantaGeorgia30308
Leann Schilling, MPH, CCRP
[email protected]
404-686-0286
Sunil Dutta, MD (PRINCIPAL_INVESTIGATOR)
New York Proton CenterNew YorkNew York10035
Ryan Holder
[email protected]
646-968-9055
Isabelle Choi, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Sangeetha Moturi
[email protected]
571-472-0343
Ashish Chawla, MD (PRINCIPAL_INVESTIGATOR)

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