Proton beam therapy plus chemo aims to improve Post-Surgery treatment for advanced endometrial cancer
NCT ID NCT04527900
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new approach called UPPROACH for people with loco-regionally advanced endometrial cancer who have had surgery. The treatment combines intensity-modulated proton beam therapy (IMPT) with standard chemotherapy (carboplatin and paclitaxel) given at the same time. The main goal is to see if more people can complete all six cycles of chemotherapy alongside the radiation compared to historical results. The study also tracks side effects, especially in the gut and urinary system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- carboplatin, paclitaxel, and proton beam therapy
- What this could lead to
- If successful, this approach could offer a more tolerable way to deliver combined radiation and chemotherapy after surgery for advanced endometrial cancer, potentially improving treatment completion rates.
- What could go wrong
- This is a small, early-phase study with only 2 participants, so results may not apply broadly. The combination may still cause side effects like gastrointestinal or urinary issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
2 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Jul 2024
- Lead sponsor
-
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelvic lymph node sampling, para-aortic lymph node sampling, and omentectomy are optional 2. Patients will be staged according to FIGO 2009 staging system. Eligibility is defined based on clinical-pathologic features. 3. Patients with endometrioid endometrial cancer with the following: * Stage IA grade 3 with extensive LVSI * Stage IB grade 3 * Stage II * Stage III (A, B, and C) * Stage IVA who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy. 4. Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stages IA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal hilum) and systemic chemotherapy. 5. Patients with a GOG Performance Status of 0, 1, or 2 6. Patients with adequate organ function, reflected by the following parameters: * WBC ≥ 3000/mcl * Absolute neutrophil count (ANC) ≥ 1000/mcl * Platelet count ≥ 100,000/mcl * SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) * Bilirubin ≤ 1.5 X ULN * Creatinine ≤ institutional ULN (if serum creatinine \> ULN, estimated GFR ≥ 45 ml/min) 7. Patients who have signed an approved informed consent and authorization permitting release of personal health information 8. Patients must be 18 years of age or older Exclusion Criteria: 1. Patients with leiomyosarcoma 2. Patients with clinically significant pelvic or para-aortic nodal disease, on post-surgery CT scan, that was not dissected and would require higher boost dose 3. Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy 4. Patients with a history of prior pelvic/abdominal RT or with history of prior cancer treatment that contraindicates this protocol therapy including history of prior chemotherapy for any other malignancy. 5. Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy 6. Patients with an estimated survival of less than three months 7. Patients with FIGO 2009 Stage IVB endometrial cancer 8. Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
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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.
Contacts and locations
Locations
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Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061, United States
-
Central Maryland Radiation Oncology
Columbia, Maryland, 21044, United States
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Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
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UMMC
Baltimore, Maryland, 21201, United States
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