[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":30,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":30,"enrollmentInfo":66,"targetDuration":30,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"CNAO National Center of Oncological Hadrontherapy","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"carbon ion radiotherapy","EXPERIMENTAL","All enrolled subjects will undergo carbon ion radiation therapy. Patients affected by pelvic recurrence of gynecological neoplasia, already undergone to radiotherapy on pelvis, will be enrolled in the study.",[13],"Radiation: carbon ion radiation therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","carbon ion radiation therapy","CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks.\n\nTreatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.",[9],[21],"CIRT",[23],{"name":24,"affiliation":5,"role":25},"Amelia Barcellini, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","390382075501",null,"amelia.barcellini@cnao.it",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Cristina Bono, MSc","390382075613","cristina.bono@cnao.it",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"CNAO","RECRUITING","Pavia","Pv","27100","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],9.15917,45.19205,{"lat":49,"lon":48},[52],{"name":33,"role":28,"phone":53,"phoneExt":30,"email":35},"0382078613",{"type":55,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100474414","clinical-study-on-the-re-irradiation-of-lateral-pelvic-recurrences-of-gynecological-malignancies-100474414",false,"NCT05457595","Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies","Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies","CYCLOPS","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Karnofsky Index ≥ 70\n* Histological or radiological diagnosis of pelvic and groin recurrence\n* Contraindications for radical surgery\n* No other distant progression or stable disease (SD) of known secondarisms (≥6 months)\n* Previous radiation therapy on pelvis\n* Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n* Possibility to perform a surgery to space the intestinal loops, in case of distance \\\u003C 10mm\n* If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.\n* DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability\n* Written informed consent\n* Patient's ability to understand the characteristics and consequences of the clinical trial\n\nExclusion Criteria:\n\n* Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan\n\n  * Intestinal infiltration\n  * Bladder infiltration\n  * Vessel infiltration\n  * Previous therapy with anti-angiogenesis drugs\n  * Psychic or other disorders that may prevent informed consent\n  * Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years\n  * Spacer in absorbable material (i.e. vycril)\n  * Distance \\\u003C 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n  * Impossibility to assess MRI","FEMALE","18 Years",{"count":67,"type":68},55,"ESTIMATED","INTERVENTIONAL",[71],"NA","The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).",[74,75,76,77],"Tumor Recurrence","Malignant Epithelial Neoplasm of Vulva","Malignant Epithelial Tumor of Ovary","Malignant Epithelial Neoplasm",[79,17,80,21],"gynecological cancer","recurrencies","2025-08-01",{"date":83,"type":84},"2025-08-06","ACTUAL",{"date":86,"type":84},"2021-02-24",{"date":88,"type":68},"2028-02-25",{"name":5,"class":6},1]