[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626418":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":46,"overallOfficials":32,"centralContacts":57,"locations":63,"responsibleParty":76,"collaborators":32,"id":80,"slug":32,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":32,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":65,"whyStopped":32,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants With Tumor Volume \u003C 12 cc Before Brachytherapy","Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc.","At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Complete Remission (CR) Rate","Defined as the disappearance of all lesions on cervical examination and imaging tests.","From treatment completion up to 2 years",{"measure":19,"description":20,"timeFrame":17},"Locoregional Control Rate","Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging.",{"measure":22,"description":23,"timeFrame":24},"Progression-Free Survival (PFS)","Assessed using the Kaplan-Meier method.","From date of enrollment to progression or death, assessed up to 2 years",{"measure":26,"description":23,"timeFrame":27},"Overall Survival (OS)","From date of enrollment to death from any cause, assessed up to 2 years",{"measure":29,"description":30,"timeFrame":31},"Incidence of Treatment-Related Adverse Events","Assessed and graded according to NCI-CTCAE version 6.0.","From the start of treatment up to 2 years",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40],{"label":41,"type":42,"description":32,"interventionNames":43},"Intra-lesional Boost Group","EXPERIMENTAL",[44,45],"Radiation: intra-lesional boost IMRT","Procedure: High Dose Rate Brachytherapy",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":32},"RADIATION","intra-lesional boost IMRT","Patients receive Whole Pelvis (+\u002F- para-aortic field) radiotherapy 45-50.4 Gy in 25-28 fractions. An intra-lesional boost is delivered using SIB technique: 15 Gy in 3 fractions to the boost target (GTVp minus 0.7-1.0 cm margin).",[41],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"PROCEDURE","High Dose Rate Brachytherapy","Followed by CT or MRI-based HDR brachytherapy. Recommended dose is 27.5-30 Gy in 4-6 fractions to the HR-CTV using Iridium-192 source.",[41],[58],{"name":59,"role":60,"phone":61,"phoneExt":32,"email":62},"Keun-Yong Eom, MD, PhD","CONTACT","82-31-787-7653","978sarang@snubh.org",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":32,"cosmosGeoPoint":70,"geoPoint":75,"contacts":32},"RECRUITING","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":71,"coordinates":72},"Point",[73,74],127.13778,37.43861,{"lat":74,"lon":73},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","KEUN YONG EOM","Clinical Assistant Professor","100626418",false,"NCT07435376","Intra-lesional Tumor Boost for Bulky Cervical Cancer","A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer","INTLECTUAL","Inclusion Criteria:\n\n* Patients with histologically confirmed squamous cell carcinoma of the cervix.\n* Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm.\n* Patients aged 19 to 80 years at the time of diagnosis.\n* Patients with an ECOG performance status of 0 to 2.\n* Patients who have voluntarily agreed to participate in the study.\n\nExclusion Criteria:\n\n* Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer).\n* Patients who are medically unfit for definitive concurrent chemoradiotherapy.\n* Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy.\n* Patients with prior history of radiation therapy to the abdomen or pelvis.\n* Patients unable to provide informed consent due to mental or physical disabilities.","FEMALE","19 Years","80 Years",{"count":91,"type":92},17,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\n* Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins?\n* What medical problems (side effects) do participants have when receiving this treatment?\n\nResearchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual.\n\nParticipants will:\n\n* Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks\n* Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size\n* Receive internal radiation therapy (brachytherapy) after finishing the external radiation\n* Visit the clinic for follow-up checkups and tests for up to 2 years",[98,99],"Cervical Cancer","Squamous Cell Carcinoma of Cervix",[101,102,103,104,105,106,107,108],"cervical cancer","bulky cervical cancer","squamous cell carcinoma","intra lesional boost","simultaneous integrated boost","imrt","radiotherapy","tumor volume reduction","2026-02-20",{"date":111,"type":112},"2026-02-27","ACTUAL",{"date":114,"type":112},"2025-02-23",{"date":116,"type":92},"2028-11-30",{"name":5,"class":6},1]