[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546389":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":37,"armGroups":46,"interventions":53,"overallOfficials":61,"centralContacts":66,"locations":74,"responsibleParty":95,"collaborators":37,"id":98,"slug":37,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":37,"enrollmentInfo":107,"targetDuration":37,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":77,"whyStopped":37,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Fundacao Champalimaud","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":37},[9,13,17,21,25],{"measure":10,"description":11,"timeFrame":12},"Dosimetric Feasibility of SBRT boost","Fulfillment of protocol dosimetrical endpoints and constraints","through study completion, an average of 3 year",{"measure":14,"description":15,"timeFrame":16},"reproducibility of SBRT boost","anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold","Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time",{"measure":18,"description":19,"timeFrame":20},"Inter\u002Fintra fractional target motion","3D deviations recorded in CBCT images and electromagnetic recording","during the 15 minutes of treatment delivery time",{"measure":22,"description":23,"timeFrame":24},"Adverse Events","Treatment related side effects based on CTCAE V5.0","through study completion, an average of 3 years",{"measure":26,"description":27,"timeFrame":24},"Local control","Free from loco-regional relapse",[29,32,34],{"measure":30,"description":31,"timeFrame":24},"Quality of life metrics","Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30",{"measure":30,"description":33,"timeFrame":24},"Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24",{"measure":35,"description":36,"timeFrame":24},"Distant Relapse","Free from distant relapse",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"NA","SINGLE_GROUP","Patients enrolled in this study must have received or planned to receive 45 to 50 Gray in 25 fractions to pelvis with a simultaneous integrated boost (SIB) of 55 Gray in 25 fractions to metabolic active primary lesion and of 55 Gray in 25 fractions to 62.5 Gray in 25 fractions suspicious nodes of prior external beam radiation therapy. Following completion, patients will receive a boost of 28 Gray in 4 fractions using Image Guided Stereotactic Body Radiation Therapy techniques.","TREATMENT",{"masking":44,"maskingDescription":37,"whoMasked":37},"NONE","This is a phase I\u002FII feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.\n\nEligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.\n\nSBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+\u002F- 1 week), at 6 months (+\u002F- 4 weeks), and then every 6 months (+\u002F- 6 weeks) until the end of the 3rd year, then annually until the 5th year.\n\nThe equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"SBRT for cervical cancer","EXPERIMENTAL","SBRT to LACC following whole pelvis external beam radiotherapy",[52],"Radiation: SBRT",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"RADIATION","SBRT","SBRT to reproduce HDR BT dose distribution in non-operated patients LACC",[48],[60],"SABR",[62],{"name":63,"affiliation":64,"role":65},"Carlo Greco, MD","Fundaçao Champalimaud","STUDY_DIRECTOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":37,"email":71},"Maria Inês Antunes, MD","CONTACT","+351210480200","ines.antunes@fundacaochampalimaud.pt",{"name":63,"role":69,"phone":70,"phoneExt":37,"email":73},"carlo.greco@fundacaochampalimaud.pt",[75],{"facility":76,"status":77,"city":78,"state":37,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Champalimaud Foundation","RECRUITING","Lisbon","1400-038","Portugal","PT",{"type":83,"coordinates":84},"Point",[85,86],-9.1498,38.72509,{"lat":86,"lon":85},[89,93],{"name":90,"role":69,"phone":91,"phoneExt":37,"email":92},"Manuela Seixas","+351 9675289072","manuela.seixas@fundacaochampalimaud.pt",{"name":68,"role":94,"phone":37,"phoneExt":37,"email":37},"PRINCIPAL_INVESTIGATOR",{"type":94,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Inês Antunes","Principal Investigator","100546389",false,"NCT06394297","VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)","A Phase I\u002FII Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)","VIBE","Inclusion Criteria:\n\n* Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy\n* Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.\n* Pelvic MRI.\n* MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.\n* Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.\n* Planning MRI with the applicator in place for the SBRT boost.\n* Para-aortic metastatic nodes below L1-L2 are allowed.\n* Study specific signed patient informed consent.\n\nExclusion Criteria:\n\n* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.\n* Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix.\n* Metastatic disease above and beyond the retroperitoneal paraaortic L1-L2 interspace.\n* Previous pelvic or abdominal radiotherapy.\n* Previous total or partial hysterectomy.\n* Contra-indications to MRI.\n* Severe psychiatric condition.\n* Severe, active co-morbidity.","FEMALE","18 Years",{"count":108,"type":109},30,"ESTIMATED","INTERVENTIONAL",[39],"This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.",[114],"Cervical Cancer",[116,117,118,119],"cervical cancer","Stereotactic body radiotherapy (SBRT)","Stereotactic ablative body radiotherapy (SABR)","Brachytherapy","2024-04-30",{"date":122,"type":123},"2024-05-01","ACTUAL",{"date":125,"type":123},"2023-08-04",{"date":127,"type":109},"2026-08-04",{"name":5,"class":6},1]