NCT07415681

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynaecologic Cancer
• Cervical Cancer
• Radiation Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-12-01
• Completion: 2033-12-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

5 sites across 1 country: United States