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NOT YET RECRUITING
NCT07415681
PHASE2

GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.

Official title: A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2026-03

Completion Date

2033-12

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

RADIATION

Volume Modulated Arc Therapy (VMAT)

VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.

RADIATION

Intensity Modulated Proton Therapy (IMPT)

IMPT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.

Locations (5)

Maryland Proton Treatment Center

Baltimore, Maryland, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Upper Chesapeake Health

Bel Air, Maryland, United States

Central Maryland Radiation Oncology

Columbia, Maryland, United States

Baltimore Washington Medical Center- Tate Cancer Center

Glen Burnie, Maryland, United States