NCT07415681RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 25 Mar 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Cervical cancer
- NCT number
- NCT07415681
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 116
- From 25 Mar 2026 to the primary completion date, 31 Dec 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Unable to lie flat during or tolerate radiation.
Other illness
- Metastatic disease beyond para-aortic lymph nodal region
- Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- Any additional active cancer that would interfere with the primary study endpoints
Lab values
- Creatine clearance \<30 mL/m2
Other
- Carcinosarcoma.
- Refusal to sign informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maryland Proton Treatment Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Upper Chesapeake Health Coordinator of this site? Confirm its status | Bel Air | United States | Recruiting |
| Central Maryland Radiation Oncology Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Baltimore Washington Medical Center- Tate Cancer Center Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.