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
1 other identifier
interventional
116
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2033
February 17, 2026
February 1, 2026
3.8 years
January 15, 2026
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
2-years following completion of treatment
Secondary Outcomes (6)
Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT
2-year following completion of treatment
Number of patients with decreased lymphocyte values at first follow-up visit post radiation
3 months post completion of RT
Number of patients with physician reported GI toxicities assessed by CTCAE v5
2 years post radiation treatment
Rates of treatment completion within scheduled time frame
2 years post treament
GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)
2 years post treatment completion
- +1 more secondary outcomes
Study Arms (2)
Photon Radiation
ACTIVE COMPARATORPhoton Radiation Therapy (Volume Modulated Arc Therapy (VMAT))
Proton Radiation
ACTIVE COMPARATORProton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- Histologic confirmation of malignancy (primary only)
- ≥ 18 years of age
- ECOG performance status ≤ 2
- 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.
- Insurance approval for IMPT
You may not qualify if:
- Metastatic disease beyond para-aortic lymph nodal region
- Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
- Cervical cancer with inability to receive concurrent chemotherapy.
- Any prior pelvic radiation.
- Treatment with other investigational agents.
- Carcinosarcoma.
- Creatine clearance \<30 mL/m2
- Unable to lie flat during or tolerate radiation.
- Refusal to sign informed consent.
- Any additional active cancer that would interfere with the primary study endpoints
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Nichols, MD
University of Maryland Medical Center/Maryland Proton Treatment Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 15, 2026
First Posted
February 17, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2033
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share