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