[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639497":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":66,"overallOfficials":45,"centralContacts":75,"locations":85,"responsibleParty":101,"collaborators":45,"id":105,"slug":45,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":45,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":130,"whyStopped":45,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Acute Toxicity","Toxicities occurring within 90 days (inclusive) from the start of radiotherapy are defined as acute toxicities. Acute toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.","Within 90 days (inclusive) from the start of radiotherapy",[14,18,22,26,30,34,38,42],{"measure":15,"description":16,"timeFrame":17},"Incidence of Late Toxicity","Toxicities occurring more than 90 days after the start of radiotherapy are defined as late toxicities. Late toxicities will be evaluated using the RTOG\u002FEORTC Late Radiation Morbidity Scoring Scheme.","From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.",{"measure":19,"description":20,"timeFrame":21},"3 years Local Recurrence Rate","The proportion of subjects who do not experience tumor recurrence or progression within the radiation field within 3 years after the end of radiotherapy.","From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.",{"measure":23,"description":24,"timeFrame":25},"3 years Distant Metastasis Rate","The proportion of subjects who develop distant metastasis within 3 years after the start of radiotherapy.","From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.",{"measure":27,"description":28,"timeFrame":29},"3 years Progression-Free Survival","The time interval from the start of radiotherapy to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause within 3 years after the start of radiotherapy.","From the start of radiotherapy until the first disease recurrence (local\u002Fregional\u002Fdistant) or death from any cause, assessed up to 3 years.",{"measure":31,"description":32,"timeFrame":33},"3 years Overall Survival","The time interval from the start of radiotherapy to death from any cause within 3 years after the start of radiotherapy.","From the start of radiotherapy until death from any cause, assessed up to 3 years.",{"measure":35,"description":36,"timeFrame":37},"3 years Disease-Free Survival","The time interval from the start of radiotherapy to the first occurrence of local or regional recurrence, distant metastasis, or death from any cause within 3 years after the start of radiotherapy.","From the start of radiotherapy until the first local\u002Fregional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.",{"measure":39,"description":40,"timeFrame":41},"Quality of Life","Quality of life will be assessed using the QLQ-C30 questionnaire, in combination with the disease-specific module (QLQ-CX24 for cervical cancer; QLQ-EN24 for endometrial cancer).","Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.",{"measure":43,"description":44,"timeFrame":33},"Treatment-Related Cost-Effectiveness Analysis","The cost assessment should cover both medical costs and non-medical costs.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.","TREATMENT",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","Randomization:\n\nIntervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.\n\nControl Group: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.\n\nStratification Factors for Randomization:Participating study center; Disease type (Cervical cancer \u002F Endometrial cancer); Receipt of concurrent chemotherapy\n\nStudy Objectives:\n\nPrimary Endpoint: Acute adverse reactions\u002Ftoxicity Secondary Endpoints: Late adverse reactions\u002Ftoxicity, 3-year local control rate, 3-year distant metastasis rate, 3-year progression-free survival (PFS), 3-year overall survival (OS), 3-year disease-free survival (DFS), quality of life, cost-effectiveness analysis related to treatment.\n\nStudy Population:\n\nPlanned Sample Size: 228 participants\n\nInclusion 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\nStudy Duration: September 2025 to September 2030 Participant Involvement Period: Follow-up for over 3 years after radiotherapy",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"MH-ART","EXPERIMENTAL","Moderately fractionated radiotherapy using online adaptive radiotherapy technology.",[60],"Radiation: Moderately fractionated radiotherapy using online adaptive radiotherapy technology",{"label":62,"type":6,"description":63,"interventionNames":64},"CF-IMRT","Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.",[65],"Radiation: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":45},"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.",[56],{"type":68,"name":63,"description":73,"armGroupLabels":74,"otherNames":45},"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.",[62],[76,81],{"name":77,"role":78,"phone":79,"phoneExt":45,"email":80},"Xiaorong Hou, Professor","CONTACT","+86 18612672203","houxr@pumch.cn",{"name":82,"role":78,"phone":83,"phoneExt":45,"email":84},"Zihan Yan","+86 17860628938","yanzihan_zora@163.com",[86],{"facility":5,"status":45,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Beijing","Beijing Municipality","100730","China","CN",{"type":93,"coordinates":94},"Point",[95,96],116.39723,39.9075,{"lat":96,"lon":95},[99,100],{"name":77,"role":78,"phone":79,"phoneExt":45,"email":80},{"name":82,"role":78,"phone":83,"phoneExt":45,"email":84},{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"SPONSOR_INVESTIGATOR","Xiaorong Hou","Professor","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":116,"type":117},228,"ESTIMATED","INTERVENTIONAL",[120],"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.",[123,124],"Cervical Cancer","Endometrial Cancer",[126,127,128,129],"Cervical cancer","Endometrial cancer","Moderately fractionated radiotherapy","Acute adverse reactions","NOT_YET_RECRUITING","2026-05-06",{"date":133,"type":134},"2026-05-13","ACTUAL",{"date":136,"type":117},"2026-06-01",{"date":138,"type":117},"2030-09-30",{"name":103,"class":6},1]