Testing a new proton therapy approach for advanced endometrial cancer
The "Upproach" Approach: A Phase 2 Study Of Upfront Intensity Modulated Proton Beam Therapy (Impt) And Concurrent Chemotherapy For Post-Operative Treatment In Loco-Regionally Advanced Endometrial Cancer
This study is testing a new type of proton therapy combined with chemotherapy to see if it can be safely given to patients with advanced endometrial cancer after surgery, while causing less harm to healthy tissues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Baltimore, Maryland and 3 other locations) |
| Trial ID | NCT04527900 on ClinicalTrials.gov |
What this trial studies
This phase 2 study aims to evaluate the treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) combined with concurrent chemotherapy for patients with loco-regionally advanced endometrial cancer. The study will compare the compliance rates of this new approach to historical data from the GOG 258 study, which utilized chemoradiation. The research will focus on patients who have undergone surgery for endometrial cancer and are recommended for adjuvant therapy. The goal is to determine if this innovative treatment can be safely administered while minimizing toxicity to surrounding healthy tissues.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced endometrial cancer who have undergone surgery and are recommended for adjuvant pelvic radiation and chemotherapy.
Not a fit: Patients with early-stage endometrial cancer or those who have not undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment compliance and reduce side effects for patients with advanced endometrial cancer.
How similar studies have performed: Preliminary data from similar approaches using proton therapy have shown promising results, but this specific combination has not been extensively tested in larger studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland and 3 other locations
- Maryland Proton Treatment Center — Baltimore, Maryland, United States (Recruiting)
- Ummc — Baltimore, Maryland, United States (Recruiting)
- Central Maryland Radiation Oncology — Columbia, Maryland, United States (Recruiting)
- Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Pranshu Mohindra, MD — University of Maryland/Maryland Proton Treatment Center
- Study coordinator: Pranshu Mohindra, MD
- Email: pmohindra@umm.edu
- Phone: 410-328-6080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.