New study aims to reduce radiation side effects for women with gynecologic cancers
NCT ID NCT07415681
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study compares two standard radiation methods—proton therapy and photon therapy—for women with newly diagnosed cervical or endometrial cancer. The goal is to see which approach causes fewer stomach and bowel side effects. About 116 participants will be randomly assigned to one of the two treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baltimore Washington Medical Center- Tate Cancer Center
RECRUITINGGlen Burnie, Maryland, 21061, United States
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Central Maryland Radiation Oncology
RECRUITINGColumbia, Maryland, 21044, United States
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Maryland Proton Treatment Center
RECRUITINGBaltimore, Maryland, 21201, United States
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University of Maryland Greenebaum Cancer Center
RECRUITINGBaltimore, Maryland, 21201, United States
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Upper Chesapeake Health
RECRUITINGBel Air, Maryland, 21014, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can hormone pills replace chemo for aggressive endometrial cancer?
- Triple oral drug combo targets two stubborn gynecologic cancers
- Can pulsed radiation extend life in metastatic cervical cancer?
- Shorter, personalized radiation may target endometrial cancer with fewer side effects
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?