[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Italian Sarcoma Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":262},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,67,93,113,137,162,183,203,223,243],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100618192","phase-2-clinical-study-in-adult-and-young-adult-patients-with-advanced-desmoplastic-small-round-cell-tumor-dsrct-isg-tulips-100618192",false,"NCT07328425","Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS","Phase II Study of Lurbinectedin and Irinotecan in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT)","ISG-TULIPS","Inclusion Criteria:\n\n1. Histological centrally confirmed diagnosis of DSRCT with the documented presence of EWSR1-WT1 translocation.\n2. Age ≥ 15 years.\n3. Locally advanced (i.e. radical surgical resection of local disease unfeasible or surgery declined by the patient or surgery deemed to become less demolitive and \u002F or easier after cytoreduction) and\u002For metastatic disease.\n4. Measurable disease by RECIST v1.1.\n5. Clinical or objective disease progression after the last administration of the last standard therapy, or have stopped standard therapy due to intolerability within 6 months from enrollment.\n6. At least one prior chemotherapy based on anthracycline (considering chemotherapy administered for primary tumour) and no more than 3 prior chemotherapy lines.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.\n8. Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days before inclusion in the trial), defined as the following:\n\n   1. platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 9.0 g\u002FdL, white blood cells ≥ 3.0 × 109\u002FL and absolute neutrophil count (ANC) ≥ 2.0 × 109\u002FL,\n   2. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × the upper limit of normal (ULN), even in the presence of liver metastases,\n   3. total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN,\n   4. International Normalized Ratio (INR) \\\u003C 1.5 (except if patient is on oral anticoagulation therapy),\n   5. calculated creatinine clearance (CrCL) ≥ 30 mL\u002Fminute (using Cockcroft-Gault formula),\n   6. creatine phosphokinase (CPK) ≤ 2.5 × ULN,\n   7. albumin ≥ 3.0 g\u002FdL.\n9. Cardiac ejection fraction ≥50% as measured by echocardiogram.\n10. Recovery to grade ≤ 1 or to baseline from any adverse event (AE) derived from previous treatment (excluding alopecia and\u002For cutaneous toxicity and\u002For fatigue grade ≤ 2).\n11. No history of arterial and\u002For venous thromboembolic event within the previous 12 months.\n12. Females of childbearing potential must have a negative pregnancy test (preferable by serum or, if serum test unavailable, urine beta-HCG) within 7 days before treatment start.\n13. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential.\n14. Male and female patients of reproductive potential must agree to employ a highly effective method of birth control (Acceptable methods of contraception are described in Appendix 5) throughout the study and thereafter, at the end of study treatment, and for at least 7 months from the patient's last lurbinectedin administration in female patients of childbearing potential and for at least 4 months in men in fertile age after the last lurbinectedin administration.\n15. The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.\n\nExclusion Criteria:\n\n1. Prior treatment with lurbinectedin or trabectedin, Ecubectedin (PM 14) or PM54.\n2. Known hypersensitivity to irinotecan or lurbinectedin or any of their components of the drugs products (excipients).\n3. Other primary malignancy with \\\u003C5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse.\n4. History or presence of unstable angina, myocardial infarction, or clinically significant valvular heart disease within 12 months of the study.\n5. Grade III\u002FIV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 12 months of study).\n6. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment within 12 months of study.\n7. Myopathy or any clinical situation that causes significant and persistent elevation of CPK (\\> 2.5 × ULN in two different determinations performed one week apart).\n8. Severe and\u002For uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).\n9. Known active brain metastasis.\n10. Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis).\n11. Diagnosis of human deficiency virus (HIV), hepatitis C virus (HCV) infection or active hepatitis B (to be excluded during the screening period).\n12. Any past or present chronic inflammatory colon and\u002For liver disease, past intestinal obstruction, pseudo or sub-occlusion or paralysis.\n13. Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and\u002For necessitating prompt local treatment within seven days.\n14. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.\n15. Known active COVID-19 disease (this includes positive test for SARS-CoV-2 in nasopharyngeal\u002Foropharyngeal swabs or nasal swabs by PCR).\n16. Prior bone marrow and\u002For stem cell transplantation, and allogenic transplant.\n17. Last dose of systemic cytotoxic therapy or investigational therapy within 21 days from enrollment.\n18. Prior treatment with any form of radiation therapy within 14 days from enrollment.\n19. Major surgery within 3 weeks prior to study entry and minor surgery within 1 week prior to study entry.\n20. Use of strong inducers of CYP3A activity within two weeks prior to the first infusion of lurbinectedin (Appendix 6).\n21. Expected limitation of the patient's ability to comply with the treatment or follow-up protocol.\n22. Subjects who have current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver metastasis or stable chronic liver disease per Investigator assessment).\n23. Subjects who have known Gilbert's syndrome.\n24. Patient has received a live or liver attenuated vaccines within 30 days before the first dose of study intervention. Killed vaccines are allowed.","ALL","15 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Patients participating in this study have DSRCT that has spread locally or to other parts of the body and can no longer be surgically removed without causing significant harm.\n\nTreatment will continue until the tumor progresses further, severe side effects occur, or either patient or investigator decision.\n\nIn addition, patients may participate in an optional biological study. The study will analyze the tumor's genes and the molecules related to them. By studying genes and their products, the investigators can better understand the behavior of the tumor and how the body responds to therapies.",[27],"Desmoplastic Small Round Cell Tumor","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":32},"2025-11-21",{"date":36,"type":21},"2030-10-01",{"name":38,"class":39},"Italian Sarcoma Group","NETWORK",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100430821","observational-study-in-localized-osteosarcoma-100430821","NCT04890067","Observational Study in Localized Osteosarcoma","Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma","ISG Os2Oss","Inclusion Criteria:\n\n* Diagnosis of high grade OS of the extremities\n* Age at diagnosis ≤ 40 years at the time of diagnosis\n* Localized disease (skip metastases are allowed)\n* Adequate organ function according the AIEOP\u002FISG OS 2021 recommendation\n* Patients or parents oe guardians of minors who have given their written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Presence of metastases\n* Diagnosis of periosteal OS, of parosteal OS or secondary OS\n* Any medical condition which can not allowed the use of the treatments recommended by AIEOP\u002FISG OS 2021","40 Years",{"count":51,"type":21},120,"OBSERVATIONAL","Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP\u002FItalian Sarcoma Group (ISG) OS 2021",[55],"Localized Osteosarcoma",[57],"Osteosarcoma","2026-03-24",{"date":60,"type":32},"2026-03-27",{"date":62,"type":32},"2021-07-30",{"date":64,"type":21},"2026-12-30",{"name":38,"class":39},16,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100391909","phase-2-trial-in-patients-with-metastatic-or-locally-advanced-leiomyosarcoma-100391909","NCT04383119","Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma","A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy","ISG-ARTICLE","Inclusion Criteria:\n\n1. Patients with histologically documented diagnosis of leiomyosarcoma\n2. Patients with diagnosis of unresectable or metastatic leiomyosarcoma\n3. Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy.\n4. Patients suitable to receive gemcitabine or trabectedin therapy.\n5. Measurable or evaluable disease with RECIST 1.1 criteria.\n6. Evidence of progression according RECIST 1.1 during the 6 months before study entry.\n7. Age ≥18 years\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n9. All previous anticancer treatments must have completed ≥ 3 weeks prior to first dose of study drug.\n10. The patient has resolution of adverse events, with the exception of alopecia, and of all clinically significant toxic effects of prior loco-regional therapy, surgery, radiotherapy or systemic anticancer therapy to ≤ Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0\n11. Adequate bone marrow, liver and renal function\n12. Left Ventricular Ejection Fraction ≥ 50% and\u002For above lower institutional limit of normality.\n13. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.\n14. No history of arterial and\u002For venous thromboembolic event within the previous 12 months.\n15. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent prior to any study specific procedure. The subject may also provide an optional consent for the biological\u002Ftranslational sub-study associated.\n\nExclusion Criteria:\n\n1. Prior treatment with Trabectedin and\u002For Gemcitabine\n2. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs\n3. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse.\n4. Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies\n5. Metastatic brain or meningeal tumors\n6. Active viral hepatitis\n7. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus\n8. Patients with any severe and\u002For uncontrolled medical conditions\n9. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment\n10. Active clinically serious infections\n11. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus\n12. Previous treatment with radiation therapy within 14 days of first day of study drug dosing,\n13. Major surgery within 4 weeks prior to study entry\n14. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors\n15. Concomitant use of known strong or moderate CYP3A inducers\n16. Patients undergoing renal dialysis or with Creatinin Clearance \\\u003C30 ml\u002Fmin or Creatinine \\>1,5 mg\u002FdL\n17. Pregnant or breast feeding patients\n18. Patients with severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol","18 Years",{"count":77,"type":21},100,[24],"Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator.\n\nIn addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option.\n\nIn order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.",[81,82],"Leiomyosarcoma of Ovary","Soft Tissue Sarcoma",[84],"advanced leiomyosarcoma",{"date":86,"type":32},"2026-03-25",{"date":88,"type":32},"2021-10-29",{"date":90,"type":21},"2026-12-31",{"name":38,"class":39},17,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":112},"100385963","phase-2-study-on-trabectedin-in-advanced-rearranged-mesenchymal-chondrosarcoma-100385963","NCT04305548","Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma","Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma","ISG-MCS","Inclusion Criteria:\n\n1. Age ≥ 16 years old\n2. Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion\n3. Locally advanced disease and\u002For metastatic disease\n4. Measurable or evaluable disease with RECIST v1.1\n5. Evidence of progression by RECIST v1.1 during the 6 months before study entry\n6. Patients must be pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of disease and with a maximum of 3 lines\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n8. Adequate bone marrow function\n9. Adequate organ function\n10. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.\n11. Cardiac ejection fraction ≥50% as measured by echocardiogram\n12. No history of arterial and\u002For venous thromboembolic event within the previous 12 months\n13. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.\n14. Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data\n\nExclusion Criteria:\n\n1. Other primary malignancy with \\\u003C5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse\n2. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered\n3. Previous radiotherapy to 25% of the bone marrow\n4. Major surgery within 2 weeks prior to study entry\n5. Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.\n6. Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous anticancer therapies.\n7. Pregnancy or breast feeding\n8. Grade III\u002FIV cardiac problems as defined by the New York Heart Association Criteria\n9. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment\n10. Known brain metastasis\n11. Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)\n12. Known diagnosis oh human deficiency virus (HIV) infection\n13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy\n14. Medical history of hemorrhage or a bleeding event ≥ Grade 3 within 4 weeks prior to the initiation of study treatment\n15. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and\u002For his\u002Fher compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results\n16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs\n17. Expected non-compliance to medical regimens","16 Years",{"count":66,"type":21},[24],"Prospective, uncontrolled, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic)",[106],"Mesenchymal Chondrosarcoma",{"date":60,"type":32},{"date":109,"type":32},"2021-09-14",{"date":90,"type":21},{"name":38,"class":39},7,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100613367","surgical-timing-after-preoperative-hypofractionated-radiotherapy-for-localized-extremity-and-trunk-soft-tissue-sarcoma-100613367","NCT07265661","Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma","Surgical Timing After Preoperative Hypofractionated Radiotherapy for Patients With Primary Localized Soft Tissue Sarcoma of the Extremity and Trunk: a Randomized Phase 2 Clinical Trial","STARS","Inclusion Criteria:\n\n* Voluntary written informed consent, with the ability to fully understand and effectively communicate, before performance of any study-related procedure not part of normal medical practice, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n* Age \\> 18 years\n* Proven diagnosis of primary, resectable extremity\u002Ftrunk wall STS with low-medium risk (Sarculator© predicted 10y-OS \\> 60%)\n* Measurable disease criteria (RECIST 1.1 and CHOI)\n* ECOG: 0, 1 or 2 (if influenced by orthopedic condition and not by general status)\n* No major contraindication to the planned radiotherapy or surgical treatment\n* Active participation with adherence to requested treatment schedule and follow-up\n* Female subject will undergo a negative pregnancy test\n* Adequate bone marrow function (hemoglobin \\> 9g\u002FdL, Leukocytes \\> 3000\u002Fmm³, platelets \\> 100,000\u002Fmm³). Patients with plasma creatinine ≤ 1.6 mg\u002FdL, transaminase (AST-SGOT, ALT-SGPT) ≤ 2.5 times the UNL; total bilirubin ≤ 1.5 time the UNL; alkaline phosphatase ≤ 2.5 times the UNL are acceptable. CRP, LDH, total protein and albumin must also be recorded.\n* HBV and HCV serologies must be performed prior to patient inclusion. If hepatitis B surface antigen (HBsAg) is positive, further evaluation is required to exclude active viral replication (i.e., testing for hepatitis B e antigen \\[HBeAg\\] and HBV DNA). If either of these markers is positive, study inclusion is not recommended. In such cases, prophylactic treatment with lamivudine may be considered at the investigator's discretion. If a potential participant tests positive for anti-HCV antibodies, active infection must be ruled out through a qualitative HCV PCR test. If PCR testing cannot be performed, or if it confirms active infection, the patient will not be eligible for the study. Patients must be HIV-seronegative, with a CD4+ T-cell count greater than 400\u002Fmm³. Individuals with clinically significant immunodeficiency-either congenital or acquired-are not eligible for enrollment\n\nExclusion Criteria:\n\n* Age \\\u003C 18y\n* Soft tissue sarcomas (STS) originating at different sites (i.e., retroperitoneal, abdominal, pelvic, head and neck), gynecological sarcomas, as well as gastrointestinal stromal tumors (GISTs), desmoid-type fibromatosis and pediatric-type sarcomas (i.e., extraosseous Ewing sarcoma, embryonal\u002Falveolar rhabdomyosarcoma, desmoplastic small round cell tumor) are excluded.\n* Recurrent or metastatic condition or previous whoop-surgery for sarcoma (incisional biopsies are allowed if performed 6 months before referral).\n* Unresectable tumors (with limb sparing surgery)\n* Diagnosed oncological condition in the 5 years before enrollment (exceptions: Gleason \\\u003C6 prostatic adenocarcinoma; In-situ cervical cancer and melanoma; basal cell skin carcinoma radically treated)\n* Prior radiation treatment to the site designated for planned surgery or radiotherapy, regardless of indication\n* Any medical condition that can impair and reduce life expectancy to less than 2 years including but not limited to significant systemic diseases grade 3 or higher on the CI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity\n* Uncontrolled bacterial, fungal, or viral infections-either systemic or localized at the site of planned surgery or radiotherapy\n* Severe psychiatric disorder, psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.\n* Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion\n* Patients who had received any other treatment for the disease under study including chemotherapy, radiotherapy, surgery or any other treatment with curative intent. incisional biopsies are allowed if performed 6 months before referral.\n* Inability to comply with the requested follow-up\n* Women who are pregnant or breast-feeding\n* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study\n* BMI \\> 40 and BMI \\\u003C 18",{"count":122,"type":21},142,[124],"NA","Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk.",[127],"Soft Tissue Sarcoma of the Trunk and Extremities","NOT_YET_RECRUITING","2026-01-02",{"date":131,"type":32},"2026-01-06",{"date":133,"type":21},"2026-01-30",{"date":135,"type":21},"2035-12-01",{"name":38,"class":39},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":145,"sex":17,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100427429","observational-study-on-skeletal-ewings-sarcoma-100427429","NCT04845893","Observational Study on Skeletal Ewing's Sarcoma","Observational Study on Treatment of Skeletal Ewing Sarcoma at Diagnosis","EWOss","Inclusion Criteria:\n\n1. Diagnosis of Ewing's sarcoma of the bone\n2. Diagnosis of Ewing-like sarcoma (round cell sarcoma with fusion of the EWSR1 gene with others not of the ETS family, sarcoma with CIC rearrangement or sarcoma with BCOR rearrangement)\n3. Diagnosis of extraosseous Ewing's sarcoma for patients\n4. Age at diagnosis \\\u003C50 years\n5. Assessment of the extent of the disease at onset in accordance with the European Society of Medical Oncology guidelines\n6. Patients or parents oe guardians of minors who have given their written informed consent to participate in the study\n\nExclusion Criteria:\n\n1\\. Presence of comorbid factors who can compromise the compliance of the treatment plan or the evaluation of the outcomes, including but not limited to organ pathologies that contraindicate the use of chemotherapy and psychological or social conditions that do not allow for adequate compliance treatment or adequate follow-up",true,"0 Years","49 Years",{"count":77,"type":21},"Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal Ewing Sarcoma",[151],"Ewing Sarcoma of Bone",[153],"Ewing Sarcoma","2025-12-30",{"date":129,"type":32},{"date":157,"type":32},"2021-06-01",{"date":159,"type":21},"2028-05-25",{"name":38,"class":39},19,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100420031","study-on-clinical-features-and-outcomes-of-breast-sarcoma-100420031","NCT04749446","Study on Clinical Features and Outcomes of Breast Sarcoma","Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes","Breast-Sarc","Inclusion Criteria:\n\n* \\>18 years at diagnosis\n* primary or secondary breast sarcoma\n* availability of medical data needed for the study (histopathological data, surgery, chemotherapy, including preceding chemotherapeutic regimens for secondary breast sarcomas, radiation therapy)\n\nExclusion Criteria:\n\n* sarcoma metastases to the breast\n* chest wall sarcomas not arising in the mammary gland\n* cutaneous sarcomas","19 Years",{"count":172,"type":21},300,"This is multi-institutional retrospective study in order to identify the most relevant clinical characteristics, treatment strategies, to explore the impact on principal clinical outcomes and finally, to suggest some principles for management and treatment of breast sarcomas.\n\nThe study will collect data about patients affected by breast sarcoma referred to participating Institutions between January 2000 and June 2020",[175],"Breast Sarcoma",{"date":129,"type":32},{"date":178,"type":32},"2021-04-02",{"date":180,"type":21},"2026-12-01",{"name":38,"class":39},14,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":202},"100284739","sacral-chordoma-surgery-versus-definitive-radiation-therapy-in-primary-localized-disease-100284739","NCT02986516","Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease","Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)","SACRO","Inclusion Criteria:\n\n* Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.\n* Age≥18years\n* ECOG-performance status (PS) 0-2\n* No previous antineoplastic therapy\n* Macroscopic tumor detectable at MRI\u002FCT scan\n* Patient amenable for surgery\n* Patient amenable for RT\n* Written informed consent given before the enrolment, according to International Conference on Harmonisation\u002Fgood clinical practice (ICH\u002FGCP).\n\nExclusion Criteria:\n\n* Distant metastasis\n* Inability to maintain treatment position\n* Prior radiotherapy to the pelvic region\n* Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)\n* Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)\n* Rectal wall infiltration\n* General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)\n* Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)\n* Severe comorbidities resulting in a prognosis of less than 6 months\n* Inability to give informed consent\n* Other malignancy within the last 5 years\n* Performance status ≥ 2 (ECOG).\n* Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n* Significant systemic diseases grade \\>3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity\n* Women who are pregnant or breast-feeding\n* Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent","80 Years",{"count":77,"type":21},[124],"Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma",[196],"Chordoma",{"date":129,"type":32},{"date":199,"type":32},"2017-03-16",{"date":90,"type":21},{"name":38,"class":39},28,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":211,"minAge":75,"maxAge":191,"enrollmentInfo":212,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100272689","observational-study-on-endometrial-stromal-tumors-100272689","NCT02829437","Observational Study on Endometrial Stromal Tumors","Endometrial Stromal Tumors: an Observational Study","EST","Inclusion Criteria:\n\n* patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014\n* Informed consent signature\n\nExclusion Criteria:\n\n* patients with different diagnosis from EST","FEMALE",{"count":77,"type":21},"Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)",[215],"Endometrial Stromal Tumors",{"date":129,"type":32},{"date":218,"type":4},"2016-10",{"date":220,"type":21},"2026-12",{"name":38,"class":39},13,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":161},"100544980","prospective-observational-study-of-localized-angiosarcoma-of-any-site-prostars-100544980","NCT06375941","Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars","ProStars","Inclusion Criteria:\n\n* pathological diagnosis of AS;\n* any site of origin;\n* any age;\n* primary, localized, resectable disease.\n\nExclusion Criteria: NA",{"count":231,"type":21},250,"This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.",[234],"Angiosarcoma","2025-11-17",{"date":237,"type":32},"2025-11-20",{"date":239,"type":32},"2024-03-29",{"date":241,"type":21},"2034-04-01",{"name":38,"class":39},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":5},"100293424","an-observational-study-on-epithelioid-sarcoma-100293424","NCT03099681","An Observational Study on Epithelioid Sarcoma","Epithelioid Sarcoma. An Observational Study","EPISObs","Inclusion criteria\n\n1. Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen\n2. Signed informed consent\n3. Adequate patient compliance to treatment or follow up\n4. No age limit\n\nExclusion criteria\n\n1. Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent\n2. Impossibility to ensure adequate compliance",{"count":77,"type":21},"Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)",[254],"Epithelioid Sarcoma",{"date":256,"type":32},"2025-11-18",{"date":258,"type":32},"2017-08-22",{"date":260,"type":21},"2030-03-31",{"name":38,"class":39},""]