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NCT07415681PHASE2Recruiting

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

University of Maryland, Baltimore

Start Date

3/25/2026

Completion Date

12/1/2033

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost 2. Histologic confirmation of malignancy (primary only) 3. ≥ 18 years of age 4. ECOG performance status ≤ 2 5. Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf. 6. Insurance approval for IMPT Exclusion Criteria: 1. Metastatic disease beyond para-aortic lymph nodal region 2. Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer. 3. FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab. 4. Cervical cancer with inability to receive concurrent chemotherapy. 5. Any prior pelvic radiation. 6. Treatment with other investigational agents. 7. Carcinosarcoma. 8. Creatine clearance \<30 mL/m2 9. Unable to lie flat during or tolerate radiation. 10. Refusal to sign informed consent. 11. Any additional active cancer that would interfere with the primary study endpoints

Interventions

RADIATION

Volume Modulated Arc Therapy (VMAT)

RADIATION

Intensity Modulated Proton Therapy (IMPT)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Gynaecologic CancerCervical CancerRadiation Therapy

Locations

Maryland Proton Treatment Center

Baltimore, Maryland 21201

United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland 21201

United States

Upper Chesapeake Health

Bel Air, Maryland 21014

United States

Central Maryland Radiation Oncology

Columbia, Maryland 21044

United States

Baltimore Washington Medical Center- Tate Cancer Center

Glen Burnie, Maryland 21061

United States