Recruiting
Phase 2

Photon vs. Proton

Sponsor:

University of Maryland, Baltimore

Code:

NCT07415681

Conditions

Gynaecologic Cancer

Cervical Cancer

Radiation Therapy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Volume Modulated Arc Therapy (VMAT)

Intensity Modulated Proton Therapy (IMPT)

Study Details

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.

Conditions

Gynaecologic Cancer

Cervical Cancer

Radiation Therapy

Study ID

NCT07415681

Start date

Mar 25, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Photon Radiation

Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))

active comparator: Proton Radiation

Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))

Interventions

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.

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.

Primary outcome measure

  • Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 [ Time Frame: 2-years following completion of treatment ]

Central Contacts and Locations

Central contacts

Locations

Maryland Proton Treatment Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

University of Maryland Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Upper Chesapeake Health

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Central Maryland Radiation Oncology

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Baltimore Washington Medical Center- Tate Cancer Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-10.