[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CNAO National Center of Oncological Hadrontherapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":232},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,69,100,130,157,177,202],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100336588","innovative-solutions-for-dosimetry-in-hadrontherapy-inside-100336588",false,"NCT03662373","Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)","Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia","INSIDE","Inclusion Criteria:\n\n* patients treated at CNAO with protons or carbon ions with horizontal beam line.\n* meningioma, ACC, skull base (clivus) chordoma, squamous cellular rhinopharynx carcinoma\n* full compatibility of the INSIDE monitoring system with all beam delivery devices in the established irradiating position\n* all emergency procedures are possible notwithstanding INSIDE system positioned.\n* signed written informed consent by patient.\n\nExclusion Criteria\n\n* missing informed consent\n* not affected by one of the selected pathologies\n* failure of pre-treatment compatibility technical assessment\n* failure of pre-treatment emergency procedures check\n* medical or individual reasons (i.e. short time test needed)","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","The study aim is to test the clinical feasibility and effectiveness of an online qualitative monitoring device named INSIDE system during hadrontherapy treatments.\n\nThis instrumentation is composed by detectors able to acquire secondary signals generated by the interaction of the primary beam with human tissues. From these measurements performed during irradiation, the INSIDE system estimates the particle beam range inside the patient's body and check the compliance of the ongoing treatment with the clinical prescription, with the aim to optimize the delivered dose.\n\nThe study aims to longitudinally monitor patients treated with hadrontherapy at the Italian National Centre of Oncological Hadrontherapy (CNAO) in Pavia in order to:\n\n* evaluate the stability of the INSIDE system response and the significance of the monitoring measurement;\n* study the clinical tolerances between ongoing and prescribed treatments within which the differences in particle range are not clinically relevant;\n* assess what impact an instrument such as the INSIDE system can have on the clinical routine;\n* evaluate the benefits of such a monitoring system with respect to treatment planning constraints.",[25],"Particle Therapy",[27,28,29],"on line monitoring","PET in beam","Hadrontherapy","RECRUITING","2025-08-06",{"date":33,"type":34},"2025-08-11","ACTUAL",{"date":36,"type":34},"2019-07-16",{"date":38,"type":21},"2025-12-31",{"name":40,"class":41},"CNAO National Center of Oncological Hadrontherapy","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100512030","hrqol-in-patients-with-solid-tumors-treated-with-hadrontherapy-100512030","NCT05947149","HRQoL in Patients With Solid Tumors Treated With Hadrontherapy","Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).","HadroQoL","Cohort A (\"survivors\"):\n\nInclusion Criteria\n\n* Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.\n* The patient is able to give consent\n\nExclusion Criteria:\n\n* Re-irradiation.\n* Second tumor.\n* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.\n\nCohort B:\n\nInclusion Criteria:\n\n* Histological and\u002For radiological diagnosis of head and neck tumors\n* Patients candidate for curative intent hadrontherapy\n* Patients ≥ 18 years of age\n* The patient is able to give consent\n\nExclusion criteria:\n\n* Re-irradiation.\n* Second tumor\n* Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life\n* Presence of diffused metastasis",{"count":52,"type":21},180,"The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.",[55,56,57],"Head and Neck Cancer","Skull Base--Cancer","Brain Cancer",[59,60,61],"cancer free survisorship","hadrontherapy","quality of life","2025-08-01",{"date":31,"type":34},{"date":65,"type":34},"2023-03-27",{"date":67,"type":21},"2025-09-26",{"name":40,"class":41},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":42},"100474414","clinical-study-on-the-re-irradiation-of-lateral-pelvic-recurrences-of-gynecological-malignancies-100474414","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",{"count":79,"type":21},55,"INTERVENTIONAL",[82],"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).",[85,86,87,88],"Tumor Recurrence","Malignant Epithelial Neoplasm of Vulva","Malignant Epithelial Tumor of Ovary","Malignant Epithelial Neoplasm",[90,91,92,93],"gynecological cancer","carbon ion radiation therapy","recurrencies","CIRT",{"date":31,"type":34},{"date":96,"type":34},"2021-02-24",{"date":98,"type":21},"2028-02-25",{"name":40,"class":41},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":109,"studyType":22,"phases":4,"briefSummary":110,"conditions":111,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":42},"100454877","longitudinal-registry-including-patients-treated-with-heavy-particles-100454877","NCT05203250","Longitudinal Registry Including Patients Treated With Heavy Particles","CNAO REgistry triAL - REGAL","Inclusion Criteria:\n\n* Patients treated with heavy particles at Fondazione CNAO, Pavia\n* Patients who have the ability to understand and be willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients or legal guardians who are unable to understand informed consent document",{"count":108,"type":21},3000,"50 Years","The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.\n\nBy keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.",[112,113,114,115,116,117],"Cancer","Oncology","Radiation Exposure","Radiotherapy Side Effect","Radiation Toxicity","Rare Disease",[29,113,112,119,120,121,122,123],"Radiotherapy","Protons","Carbon Ions","Heavy ions","Rare cancer",{"date":31,"type":34},{"date":126,"type":34},"2021-06-04",{"date":128,"type":21},"2071-06-04",{"name":40,"class":41},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":80,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":42},"100495646","simultaneous-integrated-boost-in-carbon-ion-radiotherapy-for-head-and-neck-adenoid-cystic-carcinoma-100495646","NCT05733910","Simultaneous Integrated Boost in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma","Simultaneous Integrated Boost (SIB) Planning Approach in Carbon Ion Radiotherapy for Head and Neck Adenoid Cystic Carcinoma","SIBACIRT","Inclusion Criteria:\n\n* Histologically-proven primary head and neck ACC;\n* Unresectable stage or residual macroscopic disease after surgery or multiple microscopic margins after surgery;\n* Patient with resectable tumor but refusing surgery\n* cN0\u002FpN0 - cN1\u002FpN1 patients (only ipsilateral neck levels I and II)\n* Absence of distant metastases or oligometastatic status (patients with ≤ 3 metastatic lung or bone lesions, excluding other sites;\n* No previous radiotherapy in head and neck region;\n* Karnofsky Performance Status ≥ 70;\n* Age ≥ 18 years;\n* Written informed consent\n* Patients' ability to understand the characteristics and consequences of the clinical trial.\n\nExclusion Criteria:\n\n* Local conditions contraindicating CIRT (e.g., active infection or previous history of recurrent infections in or close to the tumor site; intratumoral necrosis in strict proximity of vessels; pre-existing skin, bone or soft tissue fistula; extended mucosal involvement by the tumor; previous surgery with flap reconstruction);\n* Tumour site in nasopharynx, pharynx and tongue base (where an exclusive CIRT treatment could be at high risk of toxicity);\n* Tumor disease involving ≥ 50% of the palate with consequent high risks of serious anatomical damage in case of significant and rapid disease response to CIRT\n* Nodal involvement \\> cN1\u002FpN1 or cN1\u002FpN1 outside ipsilateral levels I and II\n* Tumor surrounding carotid artery \\> 180° or infiltrating the vessels\n* itanium surgical implants or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and may determine uncertainties in CIRT dose distribution during treatment planning\n* Presence of any comorbidity deemed to impact on treatment toxicity;\n* Psychic or other disorders that may prevent informed consent\n* Active autoimmune disease (e.g. systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis)\n* Contraindication to MRI\n* Pregnancy or breastfeeding in progress",{"count":139,"type":21},42,[82],"The investigators aim at investigating in a prospective clinical trial whether using a Simoultaneous Integrated Boost of carbon ions treatment planning approach, improving the tumor dose conformation while lowering the unintended dose to the low-risk volume, can significantly reduce the probability of toxicity without affecting Local Control.",[143,55],"Carcinoma, Adenoid Cystic",[145,60,146,147,148],"adenoid cystic carcinoma","carbon ion radiation therapy CIRT","head and neck cancer","SIB","2025-02-11",{"date":151,"type":34},"2025-02-13",{"date":153,"type":34},"2023-11-28",{"date":155,"type":21},"2026-11-28",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":42},"100507490","multi-parametric-imaging-in-personalized-radiotherapy-100507490","NCT05888064","Multi-parametric Imaging in Personalized Radiotherapy","A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy","Inclusion Criteria:\n\n* Patients with histologically confirmed diagnosis of chordoma of the skull base\n* Particle therapy with curative intent\n* Karnofsky Performance status greater than or equal to 60\n* Patients with macroscopic disease detectable at pre-radiotherapy imaging\n* Patients undergoing PT with standardized treatment procedures\n* Patients who have signed the written informed consent for research\n\nExclusion Criteria:\n\n* Metastatic disease\n* Palliative treatment\n* Other malignancies with disease-free interval \\\u003C 5 years (excepting pre- cancerous lesions)\n* Pregnancy\n* Simultaneous CHT or Immunotherapy\n* Extensive metal instrumentation\u002Fimplants\n* Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)",{"count":165,"type":21},35,"The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.",[168],"Skull Base Chordoma","2024-08-20",{"date":171,"type":34},"2024-08-21",{"date":173,"type":34},"2022-04-19",{"date":175,"type":21},"2025-08-18",{"name":40,"class":41},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":77,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":80,"phases":189,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":42},"100476049","carbon-ion-radiation-therapy-in-the-treatment-of-mucous-melanomas-of-the-female-lower-genital-tract-100476049","NCT05478876","Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract","CNAO 40-2020 C CYCLE \"Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract\" \"Radioterapia Con Ioni Carbonio Per il Trattamento Dei Melanomi Mucosi Ginecologici\"","CYCLE","Inclusion Criteria:\n\n* Histological diagnosis\n* Absence of skin extension\n* N + (only if confined to the groin and pelvis)\n* Age between 20-80 years\n* ECOG 0-2\n* No evidence of metastasis\n* At least 5 mm away with rectum and bladder wall\n* No previous RT\n* Written informed consent\n* Patient's ability to understand the characteristics and consequences of the clinical trial\n* Molecular characterization\u002F mutational state\n* Disease staging (baseline exams)\n\nExclusion Criteria:\n\n* Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan\n* Psychic or other disorders that may prevent informed consent\n* Previous invasive tumor unless patient has been disease free for at least 3 years\n* Contraindication to MRI\n* Pregnancy or breastfeeding in progress","20 Years","80 Years",{"count":188,"type":21},9,[82],"The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens.\n\nMelanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α\u002F ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).",[192,193],"Malignant Melanoma","Gynecologic Cancer",[195],"hadrontherapy, gynecological melanoma",{"date":171,"type":34},{"date":198,"type":34},"2020-09-03",{"date":200,"type":21},"2027-09",{"name":40,"class":41},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":80,"phases":212,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100456901","phase-2-immunotherapy-and-carbon-ion-radiotherapy-in-solid-cancers-with-stable-disease-100456901","NCT05229614","Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease","Immune Checkpoint Inhibitors and Carbon iON Radiotherapy In Solid Cancers With Stable Disease","ICONIC","Inclusion Criteria:\n\n1. Signed written informed consent\n2. Histologic confirmation of malignancies under treatment with single agent anti-PD1\u002FPDL1 immunotherapy per clinical practice (see cohort specific inclusion criteria) with immune checkpoint inhibitors approved by Italian national drug regulatory agencies (Agenzia Italiana del Farmaco, AIFA)\n3. Having a disease stability as assessed by AIFA monitoring sheet\n4. Presence of at least 2 measurable target lesions, of which at least one to be followed up as per RECIST and one suitable for CIRT\n5. Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n6. Females and males, 18 years of age or older (no upper limit for age)\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n8. Subjects must have measurable disease by CT or MRI per RECIST 1.1\n\nExclusion Criteria:\n\n1. Patients treated with chemo-immunotherapy associations\n2. Patients treated with immunotherapy combinations (e.g. subjects treated with anti-CTLA4 + anti-PD1\u002FPDL1 are excluded)\n3. Patients receiving immunotherapy within clinical trials\n4. Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use\n5. Patients with high tumor burden defined as \\> 10 lesions and\u002For sum of diameters \\> 19 cm\n6. Patients with distant metastases only located in the CNS are excluded\n7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n8. Patients with autoimmune diseases (ADs), including local and systemic collagen-vascular (CVD) and inflammatory bowel diseases (IBD)\n9. Previous RT, regardless of energy, on the metastatic site selected to be irradiated.\n10. Any immune-related CTCAE grade 4 adverse event, before study entry\n11. Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start\n12. Presence of metal prostheses or any other condition to prevent adequate imaging for identification of the target volume and calculation of the dose\n13. Loco-regional conditions not allowing hadron therapy (e.g. active infections in RT target region)\n14. Prisoners or subjects who are involuntarily incarcerated\n15. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)",{"count":211,"type":21},27,[213],"PHASE2","Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response.\n\nConsidering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care.",[216,217,218,219],"Non Small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Melanoma","Urothelial Carcinoma",[29,93,221,222,223,218,224],"Immunotherapy","NSCLC","HNSCC","Urothelial",{"date":171,"type":34},{"date":227,"type":34},"2022-07-26",{"date":229,"type":21},"2026-08",{"name":40,"class":41},4,""]