[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleomorphic-liposarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleomorphic-liposarcoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,86,120,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":51},"100580950","phase-1-a-study-of-mirdametinib-in-combination-with-palbociclib-in-people-with-liposarcoma-100580950",false,"NCT06843967","A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma","A Phase Ib\u002FII Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma","Inclusion Criteria:\n\nPhase I only:\n\n* A diagnosis of unresectable, recurrent, or metastatic DDLPS\n* Measurable disease as defined by RECIST 1.1\n\nPhase II only:\n\n* A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS\n* Any number of prior lines of therapy\n\n  * Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration)\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n* Absolute neutrophil count ≥ 1.5 x 109\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Platelets ≥ 100 x 109\u002FL\n* Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN, except patients with Gilbert's disease (≤3x ULN)\n* AST (SGOT) \u002FALT (SGPT) ≤ 1.5 x institutional ULN\n* Creatinine Clearance ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n\n  * Adequate coagulation function, as determined by:\n* International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \\> 1.5 × ULN is permitted but the dose must be stable for at least 2 weeks before the start of the study treatments.\n* PTT ≤ 1.5 × ULN.\n\n  * Adequate cardiac function, as determined by:\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg (Grade ≤ 2).\n* LVEF ≥ 50% by MUGA or ECHO.\n* No clinically significant ECG waveform abnormalities assessments at screening.\n\n  * Adequate glycemic control, as determined by:\n* Fasting blood glucose level \\\u003C 125 mg\u002FdL, or\n* Random blood glucose level \\\u003C 200 mg\u002FdL.\n\n  * Have normal serum calcium and phosphate levels (calcium level may be corrected for albumin level).\n  * Have intraocular pressure ≤ 21 mmHg in both eyes\n  * Women of child-bearing potential must agree to use highly effective contraceptive methods (hormonal or barrier method of birth control or abstinence) during the trial period through at least six months after the last dose. Male patients or their partners must be surgically sterile or agree to use adequate contraception while receiving trial treatment and for three months thereafter. Acceptable methods of contraceptive use by men or women are detailed in Section 15.3.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Ability to swallow tablets or capsules\n  * Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible.\n\nExclusion Criteria:\n\n* Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline.\n* Patients receiving any other investigational agents.\n* Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor\n* Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy.\n\n  * Patients with a CD4+ count of \\> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion.\n  * Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded.\n  * Patients with history of clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, clinically significant transient ischemic attack, symptomatic pulmonary embolism, unexplained syncope, or long QT syndrome within 6 months before the start of study treatment will be excluded.\n* Pregnant women and women who are breast-feeding.\n* Prolonged QTcF \\> 470ms at Screening, irrespective of sex.\n\n  o If a single 12-lead electrocardiogram (ECG) or, for patients with prolonged QT intervals or other cardiac indications, a triplicate ECG should be performed.\n* Current Chronic Kidney Disease stage \\> 3 or Creatinine Clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault method)\n* Current or history of Interstitial Lung Disease\n* History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any ophthalmological finding that could be a significant risk factor for RVO, retinopathy or neovascular macular degeneration.\n* Concurrent neuromuscular disorder that is associated with the potential of elevated CPK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* Radiation therapy within 2 weeks prior to study Day 1\n* Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.\n* Patient is receiving systemic (oral or IV\u002FSC) or ocular glucocorticoid therapy (with the exception of participants with endocrine deficiencies who are allowed to receive physiologic or stress doses of steroids, if necessary) within 14 days prior to first dose of study treatment\n* Known prior severe hypersensitivity to investigational product or any component in its formulation.\n\n  o This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Subjects with hypersensitivity to these agents will be excluded from enrollment.\n* History of significant toxicity related to prior CDK4\u002F6, MEK, or ERK inhibitor requiring discontinuation of treatments with these agents.\n* Concurrent, clinically significant, active malignancies within 12 months of study enrollment\n* Current evidence of a disorder that could reduce the ability to swallow oral dosage forms or alter absorption of orally administered drugs.\n* Patients who require concomitant use of medications that strongly induce or inhibit CYP3A or UDP-glucuronosyltransferase (UGT)\n* Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. Non-tolerable Grade 2 toxicities are defined as those with moderate symptoms that the subject is not able to endure for the conduct of instrumental activities of daily life or that persists ≥ 7 days.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.",[27,28,29,30,31,32,33,34,35],"Well Differentiated Liposarcoma","Dedifferentiated Liposarcoma","Liposarcoma","Myxoid Liposarcoma","Round Cell Liposarcoma","Myxoid Pleomorphic Liposarcoma","Pleomorphic Liposarcoma","Unresectable Liposarcoma","Unresectable Dedifferentiated Liposarcoma",[27,28,29,30,31,32,33,34,35,37,38,39],"Unresectable Well Differentiated Liposarcoma","24-344","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-05-20",{"date":43,"type":44},"2026-05-22","ACTUAL",{"date":46,"type":44},"2025-02-19",{"date":48,"type":20},"2028-08-19",{"name":39,"class":50},"OTHER",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":73,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100606316","phase-2-dose-escalated-hypofractionated-definitive-proton-radiotherapy-for-patients-with-inoperable-soft-tissue-sarcoma-100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":61,"type":20},40,[24],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[65,66,67,68,69,70,71,33,72,29],"Soft Tissue Sarcoma (STS)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Synovial Sarcomas","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma","Leiomyosarcoma (LMS)","Pleomorphic Rhabdomyosarcoma",[74,75,76],"soft tissue sarcoma","proton radiotherapy","inoperable soft tissue sarcoma","2026-01-26",{"date":79,"type":44},"2026-01-28",{"date":77,"type":44},{"date":82,"type":20},"2035-11-01",{"name":84,"class":50},"Oslo University Hospital",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":106,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100581413","phase-2-io-combined-with-ai-as-first-line-treatment-for-patients-with-soft-tissue-sarcomatais-100581413","NCT06849986","IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)","Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial","TAIS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of gender;\n* Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.\n* Patients with locally advanced disease that is not amenable to surgery\u002Fradiation therapy or with recurrent\u002Fmetastatic disease;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;\n* Expected survival of more than 3 months;\n* Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥90×10⁹\u002FL, hemoglobin ≥90g\u002FL (no blood transfusion within 14 days), serum total bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml\u002Fmin;\n* Presence of measurable lesions according to RECIST 1.1 criteria;\n* The subject (or their legal representative\u002Fguardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.\n\nExclusion Criteria:\n\nAny of the following conditions will result in exclusion from the study:\n\n* Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg\u002Fm2;\n* Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;\n* Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;\n* History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;\n* Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks prior to enrollment, and stable tumor - related clinical symptoms at the time of enrollment);\n* Clinically significant active bleeding;\n* Pregnant or lactating women; women of childbearing potential who have not taken adequate contraceptive measures;\n* Alcohol abuse or drug addiction;\n* Patients with active autoimmune diseases or a history of such diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as patients who have undergone organ transplantation and require immunosuppressive therapy). Autoimmune hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment are excluded;\n* Patients who need to receive systemic corticosteroids (equivalent to \\>10mg prednisone\u002Fday) within 14 days prior to enrollment or during the study, or those who require other immunosuppressive drug treatment. The use of topical or inhaled corticosteroids, or short - term (≤7 days) use of corticosteroids for prevention or treatment of non - autoimmune, non - frequent allergic diseases is excluded;\n* Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment;\n* History of human immunodeficiency virus infection, or other acquired or congenital immune deficiency diseases, or history of organ transplantation or stem cell transplantation;\n* Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with stable hepatitis B after drug treatment (DNA titer ≤10\\^3 copies\u002Fml), and those with cured hepatitis C (HCV RNA negative) are eligible for enrollment;\n* Severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation, or other concomitant diseases that, in the opinion of the investigator, seriously endanger the safety of the patient or affect the patient's ability to complete the study.","75 Years",{"count":96,"type":20},45,[24],"This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.",[100,101,102,103,33,104,105],"Soft Tissue Sarcomas","Angiosarcoma","Fibrosarcoma","Leiomyosarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Desmoplastic Small Round Cell Tumor",[74,107,108,109],"tislelizumab","doxorubicin","ifosfamide","2026-01-07",{"date":112,"type":44},"2026-01-08",{"date":114,"type":44},"2025-02-25",{"date":116,"type":20},"2029-12-31",{"name":118,"class":50},"Fudan University",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":130,"type":20},1582,[132],"NA","This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[135,136,137,138,101,139,28,140,141,102,142,103,143,70,33,144,145,146,67,147,148,149,150],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Alveolar Soft Part Sarcoma","Clear Cell Sarcoma of Soft Tissue","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Sarcoma","Soft Tissue Sarcoma","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Synovial Sarcoma","Undifferentiated Pleomorphic Sarcoma","NOT_YET_RECRUITING","2024-07-24",{"date":154,"type":44},"2024-07-30",{"date":156,"type":20},"2025-01-28",{"date":158,"type":20},"2032-11-01",{"name":160,"class":161},"ECOG-ACRIN Cancer Research Group","NETWORK",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100230260","phase-1-trabectedin-plus-radiotherapy-in-soft-tissue-sarcoma-patients-100230260","NCT02275286","Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","Phase I-II Prospective Trial, Multicenter, Open Label, Exploring the Combination of Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients","TRASTS","Cohort A: STS\n\nInclusion Criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Aged equal or over 18.\n3. Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy.A centralized diagnostic will be performed, the tumor sample must be available and sent prior to inclusion.\n4. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n5. Metastatic spread could be present in two organs at maximum (i.e. lungs and pelvic fosa).\n6. Those lesions considered for radiation therapy have to be considered as target lesions as well. (i.e. in a patient with nodules in lungs, those lesions selected for radiation therapy have to include at least the target lesions)\n7. It is allowed that not all the lesions will be under radiation fields. As a general rule, it will be prioritized to select, as target-irradiating lesions, those with greater increase in size and those largest lesions. It should be discouraged to irradiate pulmonary lesions with infiltration of pleural serosa.\n8. Patients must have documentation of disease progression within 6 months prior to study entry.\n9. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed as long as trabectedin has not been included.\n10. The following histological subtypes can be included:\n\n    Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma) Leiomyosarcoma Angiosarcoma\u002F epithelial hemangioendothelioma Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid\u002Fround cells, pleomorphic).\n\n    Synovial sarcoma Fibrosarcoma and its variants (epithelial fibrosarcoma\u002Flow grade fibromyxoid sarcoma) Hemangiopericytoma\u002Fsolitary fibroid tumor Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST) Myxofibrosarcoma Epithelioid Sarcoma Unclassified sarcoma (spindle cell\u002Fepithelioid\u002Fpleomorphic\u002Fmyxoid)\n11. Measurable disease, according to RECIST V 1.1 criteria\n12. Performance status ≤1 (ECOG).\n13. Adequate respiratory functions: FEV1 \\>1L; DLco \\> 40% (patients with pulmonary target lesions)\n14. Adequate bone marrow function (hemoglobin \\> 10 g\u002Fdl, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002Fdl, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n15. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n16. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n17. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study)\n18. Patient must have a Central Venous Catheter for treatment\n\nExclusion Criteria:\n\n1. Previous treatment with trabectedin or previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissues constrains)\n2. Performance status ≥ 2 (ECOG).\n3. Plasma bilirubin \\> UNL.\n4. Creatinine \\> 1.6 mg\u002FdL.\n5. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n6. Severe COPD or other severe pulmonary diseases.\n7. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n8. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n9. Uncontrolled bacterial, mycotic or viral infections.\n10. Known positive test for infection by human immunodeficiency virus (HIV).\n11. Women who are pregnant or breast-feeding.\n12. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n13. Patients participating in another clinical trial or receiving any other investigational product\n14. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n15. Histologies other than those described in inclusion criteria.\n\nCohort B: ML\n\nInclusion criteria:\n\n1. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.\n2. Age ≥18 years old.\n3. Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm. A centralized diagnostic will be performed to confirm that the patient can be included in the study.\n4. Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.\n5. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.\n6. Measurable disease, according to RECIST V 1.1 criteria\n7. Performance status 0-1 (ECOG).\n8. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, leukocytes ≥ 3.000\u002Fmm3, neutrophils ≥ 1.500\u002Fmm3, platelets ≥ 100.000\u002Fmm3). Patients with plasma creatinine ≤ 1,6 mg\u002FdL, transaminases ≤ 2.5 times the UNL, total bilirubin ≤ UNL, CPK ≤ 2.5 times UNL, alkaline phosphatase ≤ 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is \\> 2.5 times the UNL, then the alkaline phosphatase liver fraction and\u002For GGT must be ≤ UNL.\n9. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.\n10. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n11. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA HBV+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).\n12. Patient may have had one previous chemotherapy line.\n13. Patient must have a Central Venous Catheter for treatment.\n\nExclusion criteria:\n\n1. Unresectable tumors (with limb sparing surgery)\n2. More than one previous chemotherapy treatment for local disease including trabectedin.\n3. Radiotherapy involving the tumoral bed.\n4. Performance status ≥ 2 (ECOG).\n5. Presence of metastases or lymph node involvement by the tumor.\n6. Location other than limb or superficial trunk wall.\n7. Plasma bilirubin \\> UNL.\n8. Creatinine \\> 1.6 mg\u002FdL.\n9. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.\n10. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n11. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.\n12. Uncontrolled bacterial, mycotic or viral infections.\n13. Known positive test for infection by human immunodeficiency virus (HIV).\n14. Women who are pregnant or breast-feeding.\n15. Psychological, familial, social or geographic circumstances that limit the patient\"s ability to comply with the protocol or informed consent.\n16. 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\nCohorts C and D: Retroperitoneum sarcoma\n\nInclusion criteria:\n\n1. The patient must voluntarily sign the informed consent form before performing any study-specific test that is not part of the patient's usual care.\n2. Aged between 18 and 75 years.\n3. The following histological subtypes may be included in the cohort C:\n\n   High grade leiomyosarcoma (G2-3), liposarcoma (G2-3), if at least 30% of the tumour is dedifferentiated, pleomorphic liposarcoma.\n\n   The following histological subtypes may be included in the cohort D:\n\n   Well differentiated liposarcoma (WD liposarcoma) and G2 dedifferentiated liposarcorcoma, if less than 30% of the tumour is dedifferentiated.\n\n   A centralised diagnosis will be made to confirm that the patient can be included in the study.\n4. The tumour must be located in the retroperitoneum and it must be resectable and without evidence of regional or distal spread after the appropriate staging process. This point must be confirmed by the central surgeon reviewer.\n5. The location and size of the disease in the retroperitoneum must allow for compliance with radiotherapy limitations in healthy tissue. This point must be confirmed by the site's radiation oncologist and the central radiation oncologist reviewer.\n6. Measurable disease according to CHOI criteria for cohort C and RECIST V 1.1 criteria for cohort D.\n7. ECOG performance status 0-1.\n8. Adequate haematological parameters (haemoglobin \\>10 g\u002Fdl, leukocytes ≥3,000\u002Fmm3, neutrophils ≥1,500\u002Fmm3, platelets ≥100,000\u002Fmm3). Patients with plasma creatinine ≤1.6 mg\u002Fdl, transaminases ≤2.5 times the ULN, total bilirubin ≤ ULN, CPK ≤2.5 times ULN, alkaline phosphatase ≤2.5 times ULN are acceptable. If the increase in alkaline phosphatase is \\>2.5 times the ULN, the liver fraction of alkaline phosphatase and\u002For GGT should be ≤ULN.\n9. Fertile men or women must use an effective contraceptive method before starting the study, during the study and for 6 months following the conclusion thereof. Women of childbearing potential who participate in the study must undergo a pregnancy test before starting the study.\n10. Normal cardiac function with LVEF ≥50% by echocardiogram or MUGA.\n11. HBV and HCV serology must be performed before including the patient in the study. If HbsAg is positive, it is advisable to rule out a replicative phase (HbsAg\\*, DNA HBV+). If positive, the patient's inclusion in the trial is not recommended, and it is at the discretion of the investigator to administer preventive treatment with lamivudine. If a potential patient is positive to anti-HCV antibodies, the presence of the virus will be ruled out with a qualitative PCR, or the patient cannot be included in the study (if the qualitative PCR test cannot be performed on the patient, they cannot be included in the study).\n12. Patient may have had one previous chemotherapy line (cohort D only).\n13. The patient must have a central venous catheter for the administration of the treatment.\n\nExclusion criteria\n\n1. Unresectable tumours.\n2. Location other than the retroperitoneum.\n3. Patients who have previously received systemic treatment with chemotherapy (trabectedin included). For cohort D, patients may have received one previous line of chemotherapy with any other agent.\n4. Patients who underwent prior local treatment for retroperitoneal sarcoma: surgery or radiotherapy in the tumour bed.\n5. ECOG performance status ≥2.\n6. Presence of metastasis or lymph node involvement of the tumour.\n7. Previous history of another neoplastic disease with less than 5 years free of disease except for basal cell carcinoma or properly treated in situ cervical cancer.\n8. Significant cardiovascular disease (e.g. dyspnoea \\>2 NYHA).\n9. A significant grade 3 or greater systemic disease on the NCI-CTCAE v4.03 scale, which may limit the availability of the patient or which, in the opinion of the investigator, may contribute to the toxicity caused by the study treatment.\n10. Uncontrolled viral, mycotic or bacterial infections.\n11. Known HIV-positive patients.\n12. Pregnant or breast-feeding women.\n13. Psychological, familial, social or geographical circumstances that limit the patient's ability to comply with the protocol or informed consent form.\n14. Patients who have participated in another clinical trial and\u002For have received another investigational product in the 30 days prior to inclusion in the trial.",{"count":171,"type":20},199,[23,24],"Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients:\n\nCohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.\n\nCohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma).\n\nCohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component).\n\nPhase I: escalating dose of 1.3 or 1.5 mg\u002Fm2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg\u002Fm2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy\u002Ffraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy\u002Ffraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy\u002Ffraction).\n\nRadiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy\u002Ffraction). A translational substudy is developed to analyse different biomarkers predictive value.\n\nCohorts A and B are closed to recruitment in 2023.",[175,176,103,29,33],"Liposarcoma, Myxoid","Sarcoma, Soft Tissue",[178],"sarcoma","2023-05-29",{"date":181,"type":44},"2023-05-31",{"date":183,"type":44},"2014-11",{"date":185,"type":20},"2028-06",{"name":187,"class":50},"Grupo Espanol de Investigacion en Sarcomas",17]