[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658793":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":37,"overallOfficials":43,"centralContacts":48,"locations":24,"responsibleParty":54,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":24,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":77,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":24},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of radiation dose de-escalation","Defined as \\>=66% of subjects (\\>=13\u002F20) treated with the study definition of vaginal dose de-escalation","approximately 5 weeks",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Safety of reducing vaginal radiation dose","defined as crude incidence of vaginal recurrence not greater than 15% (3\u002F20)","3 years",{"measure":19,"description":20,"timeFrame":17},"Late vaginal toxicity","measured descriptively based on physician reported grading and speculum measurements of vaginal length, caliber, and distensibility.",{"measure":22,"description":23,"timeFrame":17},"Sexual health outcomes","measured using the Female Sexual Function Index (FSFI) questionnaire with a higher score indicating a better outcome",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32],{"label":33,"type":34,"description":24,"interventionNames":35},"Vaginal dose de-escalation","EXPERIMENTAL",[36],"Radiation: radiation dose de-escalation",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":24},"RADIATION","radiation dose de-escalation","Participants will have brachytherapy delivered in a way that targets the cervical cancer while limiting the amount of radiation to the vagina and will complete quality of life questionnaires.",[33],[44],{"name":45,"affiliation":46,"role":47},"Junzo Chino, MD","Duke Health","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":24,"email":53},"Clinical Trials Office","CONTACT","(919) 668-3726","RadOnc-Clinical_Trials@dm.duke.edu",{"type":55,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100658793","vaginal-dose-de-escalation-during-brachytherapy-for-cervical-cancer-100658793",false,"NCT07855263","Vaginal Dose De-escalation During Brachytherapy for Cervical Cancer","PreserV: A Feasibility Study of Vaginal Dose De-escalation During Brachytherapy in Patients With Cervical Cancer","PreserV","Inclusion Criteria:\n\n* Adult subjects aged 18 years or older\n* Must be able to provide study specific informed consent prior to study entry\n* Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the cervix\n* Stage I-III according to the International Federation of Gynecology and Obstetrics (FIGO) 2018 edition (excepting FIGO IIA and IIIA, both indicating vaginal involvement)\n* Supraclavicular nodal involvement is allowed (selected FIGO IVB) if there is no vaginal involvement\n* Patients with oligometastatic disease (1-4 sites, addressable by surgery, SBRT or other definitive treatment) are allowed, if treated with curative doses to pelvic disease.\n* ECOG performance status of 0-2\n* The plan of care must include external beam radiation (with or without concurrent chemotherapy) followed by brachytherapy.\n\nExclusion Criteria:\n\n* Disease involving the vagina\n* Patients with Stage IVB disease according to the FIGO 2018 edition (with the exception of supraclavicular nodal disease, or oligometastatic disease as noted in inclusion)\n* Any active malignancy within the previous 2 years that may alter the course of the current cancer treatment;\n* Prior pelvic radiotherapy that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","FEMALE","18 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[26],"The purpose of this study is to determine if it is possible to reduce the amount of radiation that the vagina receives during brachytherapy treatment, and to see how the change in radiation dose to the vagina impacts quality of life.",[73],"Cervical Cancer",[75,76],"brachytherapy","radiation therapy","NOT_YET_RECRUITING","2026-09-28",{"date":80,"type":81},"2026-10-02","ACTUAL",{"date":83,"type":68},"2026-12",{"date":85,"type":68},"2032-02",{"name":5,"class":6}]