[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624903":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":94,"collaborators":42,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":42,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":42,"enrollmentInfo":106,"targetDuration":42,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":42,"overallStatus":117,"whyStopped":42,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photon Radiation","ACTIVE_COMPARATOR","Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))",[13],"Radiation: Volume Modulated Arc Therapy (VMAT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Proton Radiation","Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))",[18],"Radiation: Intensity Modulated Proton Therapy (IMPT)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Volume Modulated Arc Therapy (VMAT)","VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions\n\nAll patients will receive concurrent cisplatin 40 mg\u002Fm2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.",[9],[26],"Arm 1",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Intensity Modulated Proton Therapy (IMPT)","IMPT- 45-50.4 Gy in 1.8-2 Gy fractions\n\nAll patients will receive concurrent cisplatin 40 mg\u002Fm2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.",[15],[32],"Arm 2",[34],{"name":35,"affiliation":36,"role":37},"Elizabeth Nichols, MD","University of Maryland Medical Center\u002FMaryland Proton Treatment Center","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","410-328-6080",null,"enichols1@umm.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Caitlin Eggleston, MPH","410-369-5351","caitlineggleston@umm.edu",[49,62,67,76,85],{"facility":50,"status":42,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":42},"Maryland Proton Treatment Center","Baltimore","Maryland","21201","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-76.61219,39.29038,{"lat":60,"lon":59},{"facility":63,"status":42,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":64,"geoPoint":66,"contacts":42},"University of Maryland Greenebaum Cancer Center",{"type":57,"coordinates":65},[59,60],{"lat":60,"lon":59},{"facility":68,"status":42,"city":69,"state":52,"zip":70,"country":54,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":42},"Upper Chesapeake Health","Bel Air","21014",{"type":57,"coordinates":72},[73,74],-76.34829,39.53594,{"lat":74,"lon":73},{"facility":77,"status":42,"city":78,"state":52,"zip":79,"country":54,"countryCode":55,"cosmosGeoPoint":80,"geoPoint":84,"contacts":42},"Central Maryland Radiation Oncology","Columbia","21044",{"type":57,"coordinates":81},[82,83],-76.83942,39.24038,{"lat":83,"lon":82},{"facility":86,"status":42,"city":87,"state":52,"zip":88,"country":54,"countryCode":55,"cosmosGeoPoint":89,"geoPoint":93,"contacts":42},"Baltimore Washington Medical Center- Tate Cancer Center","Glen Burnie","21061",{"type":57,"coordinates":90},[91,92],-76.62469,39.16261,{"lat":92,"lon":91},{"type":37,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Elizabeth Nichols","Principal Investigator","100624903","phase-2-gccc-2578-randomized-photon-vs-proton-rt-for-newly-diagnosed-gynecologic-primaries-100624903",false,"NCT07415681","GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries","A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries","Inclusion Criteria:\n\n1. a. Newly diagnosed endometrial cancer after TAH\u002FBSO 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\n2. Histologic confirmation of malignancy (primary only)\n3. ≥ 18 years of age\n4. ECOG performance status ≤ 2\n5. 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.\n6. Insurance approval for IMPT\n\nExclusion Criteria:\n\n1. Metastatic disease beyond para-aortic lymph nodal region\n2. Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.\n3. FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.\n4. Cervical cancer with inability to receive concurrent chemotherapy.\n5. Any prior pelvic radiation.\n6. Treatment with other investigational agents.\n7. Carcinosarcoma.\n8. Creatine clearance \\\u003C30 mL\u002Fm2\n9. Unable to lie flat during or tolerate radiation.\n10. Refusal to sign informed consent.\n11. Any additional active cancer that would interfere with the primary study endpoints","FEMALE","18 Years",{"count":107,"type":108},116,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","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.",[114,115,116],"Gynaecologic Cancer","Cervical Cancer","Radiation Therapy","NOT_YET_RECRUITING","2026-02-09",{"date":120,"type":121},"2026-02-17","ACTUAL",{"date":123,"type":108},"2026-03",{"date":125,"type":108},"2033-12",{"name":5,"class":6},5]