[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-epithelial-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-epithelial-neoplasm":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29],"Tumor Recurrence","Malignant Epithelial Neoplasm of Vulva","Malignant Epithelial Tumor of Ovary","Malignant Epithelial Neoplasm",[31,32,33,34],"gynecological cancer","carbon ion radiation therapy","recurrencies","CIRT","RECRUITING","2025-08-01",{"date":38,"type":39},"2025-08-06","ACTUAL",{"date":41,"type":39},"2021-02-24",{"date":43,"type":20},"2028-02-25",{"name":45,"class":46},"CNAO National Center of Oncological Hadrontherapy","OTHER",""]