[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639497":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MH-ART","EXPERIMENTAL","Moderately fractionated radiotherapy using online adaptive radiotherapy technology.",[13],"Radiation: Moderately fractionated radiotherapy using online adaptive radiotherapy technology",{"label":15,"type":6,"description":16,"interventionNames":17},"CF-IMRT","Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.",[18],"Radiation: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Moderately fractionated radiotherapy using online adaptive radiotherapy technology","Treatment will be delivered using an online adaptive radiotherapy device. A moderately fractionated regimen will be employed, with a prescribed dose of 40.05 Gy in 15 fractions, administered once daily, five times per week.",[9],null,{"type":21,"name":16,"description":27,"armGroupLabels":28,"otherNames":25},"Intensity-modulated radiotherapy techniques will be used, including FF-IMRT, VMAT, or TOMO. A conventionally fractionated regimen will be employed, with a prescribed dose of 45 Gy in 25 fractions, administered once daily, five times per week.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Xiaorong Hou, Professor","CONTACT","+86 18612672203","houxr@pumch.cn",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Zihan Yan","+86 17860628938","yanzihan_zora@163.com",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing","Beijing Municipality","100730","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Xiaorong Hou","Professor","100639497","mh-art-vs-cf-imrt-in-postoperative-cervicalendometrial-cancer-100639497",false,"NCT07584161","MH-ART vs CF-IMRT in Postoperative Cervical\u002FEndometrial Cancer","A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy（MH-ART） vs. Conventional Fractionated Intensity-Modulated Radiotherapy（CF-IMRT） in Postoperative Cervical Cancer and Endometrial Cancer","ARTISAN","Inclusion Criteria:\n\n1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.\n2. Age ≥18 years and ≤75 years.\n3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.\n4. Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and\u002For para-aortic lymph node dissection\u002Fsampling or sentinel lymph node biopsy).\n5. For participants with cervical cancer, the following criteria must be met:\n\n(1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.\n\n(2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.\n\nOther risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.\n\n6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1.\n\nNon-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).\n\n7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.\n\n8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.\n\n9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.\n\nExclusion Criteria:\n\n1. Presence of confirmed distant metastasis or para-aortic lymph node metastasis;\n2. Requirement for extended-field radiotherapy encompassing the para-aortic region;\n3. Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered;\n4. History of previous abdominal or pelvic radiotherapy;\n5. History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary\u002Ffollicular thyroid carcinoma, or carcinoma in situ of the breast);\n6. History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;\n7. Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types;\n8. Pregnant or lactating women;\n9. Presence of active infection or fever;\n10. Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.","FEMALE","18 Years","75 Years",{"count":71,"type":72},228,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is an investigator-initiated, prospective, national multi-center, phase III, randomized, open-label, non-inferiority clinical study. The hypothesis is that using online adaptive radiotherapy technology for moderately fractionated radiotherapy in post-operative patients with cervical\u002Fendometrial cancer may reduce radiotherapy-related toxicity and improve quality of life while ensuring target coverage. The objective is to evaluate treatment-related toxicity and efficacy of moderately fractionated online adaptive radiotherapy compared to conventionally fractionated intensity-modulated radiotherapy in post-operative cervical and endometrial cancer patients, aiming to provide a more precise, convenient, and cost-effective treatment option for patients.",[78,79],"Cervical Cancer","Endometrial Cancer",[81,82,83,84],"Cervical cancer","Endometrial cancer","Moderately fractionated radiotherapy","Acute adverse reactions","NOT_YET_RECRUITING","2026-05-06",{"date":88,"type":89},"2026-05-13","ACTUAL",{"date":91,"type":72},"2026-06-01",{"date":93,"type":72},"2030-09-30",{"name":57,"class":6},1]