GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries
Sponsor: University of Maryland, Baltimore
ClinicalTrials ID:NCT07415681
This study evaluates side effects of photon vs. proton radiation in endometrial and cervical cancer patients. Eligible participants are adults with newly diagnosed cancer, confirmed malignancy, ECOG ≤ 2, and insurance for IMPT. Interventions include VMAT or IMPT radiation, both with concurrent weekly cisplatin during EBRT, excluding chemotherapy during HDR brachytherapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Metastatic disease beyond para-aortic lymph nodal region
- Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- 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.
- Carcinosarcoma.
- Creatine clearance <30 mL/m2
- Unable to lie flat during or tolerate radiation.
- Refusal to sign informed consent.
- Any additional active cancer that would interfere with the primary study endpoints
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Maryland Proton Treatment Center | 21201 | Baltimore | Maryland |
| University of Maryland Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Upper Chesapeake Health | 21014 | Bel Air | Maryland |
| Central Maryland Radiation Oncology | 21044 | Columbia | Maryland |
| Baltimore Washington Medical Center- Tate Cancer Center | 21061 | Glen Burnie | Maryland |
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