[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiaorong Hou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},228,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Cervical Cancer","Endometrial Cancer",[31,32,33,34],"Cervical cancer","Endometrial cancer","Moderately fractionated radiotherapy","Acute adverse reactions","NOT_YET_RECRUITING","2026-05-06",{"date":38,"type":39},"2026-05-13","ACTUAL",{"date":41,"type":22},"2026-06-01",{"date":43,"type":22},"2030-09-30",{"name":45,"class":46},"Xiaorong Hou","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100601877","clinical-research-on-moderately-hypofractionated-adaptive-postoperative-radiotherapy-for-high-risk-endometrial-cancer-100601877","NCT07116213","Clinical Research on Moderately Hypofractionated Adaptive Postoperative Radiotherapy for High-Risk Endometrial Cancer","Inclusion Criteria:\n\n* Age : 18-70 years old.\n* Performance Status :\n\nECOG score 0-2.\n\n* Expected to comply with oART (Online Adaptive Radiotherapy) workflow.\n* Initial Surgical Treatment :\n\nTotal hysterectomy and bilateral salpingo-oophorectomy ± Pelvic and\u002For para-aortic lymph node dissection\u002Fsampling or sentinel lymph node biopsy.\n\n* Pathological Staging \\& Histology (per FIGO 2009):\n\nStage I :\n\nGrade 3 endometrioid adenocarcinoma with superficial myometrial invasion and extensive LVSI (Lymphovascular Space Invasion).\n\nGrade 2 endometrioid adenocarcinoma with deep myometrial invasion and extensive LVSI.\n\nGrade 3 endometrioid adenocarcinoma with deep myometrial invasion. Stage II-IIIC1 : Endometrioid carcinoma. Stage I-IIIC1 : Serous carcinoma or clear cell carcinoma.\n\n* Informed Consent :\n* Patients and families fully understand the study protocol.\n* Voluntarily participate and sign informed consent forms before enrollment\n\nExclusion Criteria:\n\n* Prior Radiotherapy : History of abdominal or pelvic irradiation.\n* Treatment Interval :\n\nWithout adjuvant chemotherapy: \\>12 weeks between surgery and radiotherapy initiation.\n\nWith adjuvant chemotherapy: \\>6 months between surgery and radiotherapy initiation.\n\n* Malignancy History : Prior diagnosis of other malignancies.\n* Pregnancy\u002FLactation : Pregnant or breastfeeding women.\n* Active Infection : Fever or uncontrolled active infection.\n* Inflammatory Bowel Disease (IBD) : History of IBD (regardless of activity status).\n* Comorbidities : Severe conditions affecting trial compliance, including: Unstable cardiac disease requiring treatment, renal impairment, chronic hepatitis, poorly controlled diabetes, psychiatric disorders","70 Years",{"count":56,"type":22},20,[25],"1. Study Type: Single-center, single-arm, prospective study.\n2. Sample Size: 20 patients with high-risk endometrial cancer were enrolled.\n3. Treatment Procedure:\n\n   The existing clinical oART (Online Adaptive Radiotherapy) workflow protocol for malignant tumors used in our department was applied.\n\n   Procedures included simulation, target volume delineation, radiotherapy planning, and treatment delivery.\n\n   External beam radiation therapy (EBRT) was delivered using moderate hypofractionation.\n\n   If indicated, brachytherapy was performed after the completion of EBRT. When combined with chemotherapy, radiotherapy could be administered during chemotherapy intervals or after completion of chemotherapy.\n4. Study Endpoints:\n\nPrimary Endpoint: Incidence of acute toxicity. Secondary Endpoints: 3-year failure-free survival (FFS) rate, incidence of chronic toxicity, quality of life (QoL), treatment costs, etc.",[29,60,61,62,63],"Hypofractionated Dose","Radiotherapy, Adjuvant","Side Effects","Survival , Tumor",[65,66,67],"endometrial cancer","Hypofractionated dose","Radiotherapy","RECRUITING","2025-08-04",{"date":71,"type":39},"2025-08-11",{"date":73,"type":39},"2025-06-30",{"date":75,"type":22},"2030-12-30",{"name":45,"class":46},""]