[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcoma-soft-tissue\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcoma-soft-tissue":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,67,96,124,150,177,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100631607","deep-phenotyping-gait-deficits-in-orthopedic-manifestations-of-pediatric-cancer-patients-100631607",false,"NCT07502885","Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients","Inclusion Criteria\n\nCases:\n\n* Participant requiring orthopedic surgery due to a diagnosis of lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis (Appendix III) and will receive further additional treatment and\u002For follow-up care at St. Jude.\n* Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.\n\nControls:\n\n* Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.\n* Participant (or their parent\u002Flegal guardian) considers themself healthy for their age.\n* Participant (or their parent\u002Flegal guardian) reports being able to participate in normal daily activities of life with respect to their age.\n\nExclusion Criteria\n\nCases:\n\n* Individuals with pre-existing genetic\u002Fcongenital disorders affecting gait will be excluded e.g., cerebral palsy.\n* Individuals who are unable to follow age-appropriate instructions during the gait assessment.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Individuals diagnosed with radiation-induced avascular necrosis.\n\nControls:\n\n* Individuals who are unable to follow age-appropriate instructions during the gait assessment.\n* Individuals who self-report health conditions affecting gait and mobility.\n* Individuals who have the following conditions: diabetes mellitus due to impaired circulation, sensation and strength, malignant cancers, demyelinating inflammatory and degenerative neurological conditions, pregnancy, obesity (BMI \\>40 kg\u002Fm2), severe cardiac or pulmonary disease affecting performance of daily activities, history of major surgery affecting gait and mobility, infections or inflammatory arthropathies, severe mobility impairment necessitating dependence on mobility aids for all ambulation.\n* Individual or legal guardian\u002Frepresentative is unable or unwilling to give written informed consent.",true,"ALL","5 Years","20 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The goal of DEEPGAIT study is to determine how serious walking problems are for pediatric cancer patients who have had orthopedic surgery, how they change over time, and what can be done to help. Healthy participants without cancer will also be included in this study in order to better understand the difference in walking problems between the 2 groups.\n\nDEEPGAIT is a long term study that uses advanced tools-including 3D motion capture, muscle sensors, force plates, and wearable devices-to take a detailed look at how these patients move. Their results are compared to healthy children of the same age and sex.\n\nPRIMARY OBJECTIVES\n\n* Characterize gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.\n* Identify personal, disease, treatment and environment risk factors for gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.\n\nSECONDARY OBJECTIVES\n\n* Build a library of broadly representative normative reference values to generate age- and sex-matched z-scores to quantify frequency, severity and progression of gait deficits among pediatric cancer patients in relation to healthy controls.\n* Characterize the changes of gait parameters in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.\n* Identify personal, disease, treatment and environment risk factors for trajectories of gait deficits in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.",[25,26,27],"Sarcoma, Bone","Sarcoma, Soft Tissue","Gait Disorder","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":29,"type":32},{"date":35,"type":21},"2032-01",{"name":37,"class":38},"St. Jude Children's Research Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100615337","phase-2-metformin-hydrochloride-in-combination-with-standard-of-care-systemic-therapy-in-previously-untreated-advanced-unresectable-or-metastatic-soft-tissue-sarcoma-100615337","NCT07291297","Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Advanced unresectable or metastatic\u002Fintermediate\u002Fhigh grade soft tissue sarcoma\n2. Age ≥ 18 years at the time of enrollment\n3. Initiating first line systemic therapy for advanced\u002Fmetastatic disease (treatment naïve for advanced\u002Fmetastatic disease)\n\n   1. Participants who have not yet initiated first line systemic therapy: expected to initiate front-line therapy within 4 weeks of initiating metformin\n   2. Participants who have previously initiated first line systemic therapy: No more than 4 weeks from initiation of first line systemic therapy\n4. Adequate performance status (PS) defined as ECOG PS = 0-2\n5. Adequate renal function\n6. Adequate liver function\n7. Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test within 7 days prior to enrollment. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). Metformin is known to be excreted in breast milk and should not be used by nursing mothers.\n8. ICBP and partners of ICBP must not be expecting to conceive and be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \\\u003C1% per year when used consistently and correctly) from the time of informed consent until 30 days after study treatment discontinuation.\n9. Individuals who are having sexual relationships in which their partners may become pregnant must be willing to use condoms from the time of informed consent until 30 days after study treatment discontinuation. For a non-pregnant ICBP partner, contraception recommendations should also be considered.\n10. Ability to ingest oral medications\n\nExclusion Criteria:\n\n1. Already prescribed and taking metformin at time of diagnosis of advanced unresectable or metastatic disease\n2. Planned enrollment on a treatment clinical trial for first line therapy\n3. Breastfeeding within the duration of anticipated study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.\n4. History of acute or chronic metabolic acidosis including diabetic ketoacidosis, with or without coma.\n5. Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include ductal carcinoma in situ (DCIS), basal cell or squamous cell skin cancer and in situ cervical or bladder cancer.\n6. Treatment with any investigational drug within 14 days prior to day 1 of treatment\n7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin. Participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible. Lists including medications and substances known or with the potential to interact with the specified CYP450 enzyme(s) isoenzymes. Please refer to https:\u002F\u002Fdrug-interactions.medicine.iu.edu\u002FMainTable.aspx for the most current information.\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure requiring pharmacologic treatment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the investigator.\n9. Patients with known brain or active central nervous system (CNS) metastases.","18 Years",{"count":48,"type":21},50,"INTERVENTIONAL",[51],"PHASE2","The purpose of this research study is to see how metformin, when used in combination with standard of care (SOC) treatment for metastatic (cancer that has spread) soft tissue sarcoma can improve patient outcomes.",[54,26],"Sarcoma Metastatic",[56,57],"Advanced Unresectable or Metastatic Soft Tissue Sarcoma","Metformin Hydrochloride","2026-03-04",{"date":60,"type":32},"2026-03-05",{"date":58,"type":32},{"date":63,"type":21},"2033-10",{"name":65,"class":38},"Wake Forest University Health Sciences",2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":49,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100598456","short-course-of-radiotherapy-prior-to-surgery-of-soft-tissue-sarcomas-100598456","NCT07071727","Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas","Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial","SCOPES II","Inclusion Criteria:\n\n* Histologically confirmed intermediate to high grade soft tissue sarcoma localized to the head and neck area, to the trunk and chest wall or to the extremities, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and\u002For ≥ 5cm in largest tumor diameter and\u002For an anticipated close resection margin and\u002For grade II\u002FIII according to the FNCLCC definition);\n* Absence of regional and\u002For distant disease. Patients must be staged by at least a CT scan of the chest. Staging may also be performed by FDG-PET scanning and\u002For total body MRI scans;\n* WHO Performance Status ≤ 2;\n* Able and willing to undergo preoperative radiotherapy;\n* Able and willing to undergo definitive surgery;\n* Able and willing to comply with regular follow-up visits;\n* Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);\n* Able and willing to undergo randomization;\n* Age ≥ 18 years;\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;\n* Patients with locally recurrent sarcomas, regardless of the management of the first sarcoma diagnosis;\n* Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;\n* Myxoid liposarcomas, because they have shown to be exquisitely sensitive to a lower dose of radiation as compared to the 2 regimens tested in this trial.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n* Female patients who are pregnant;\n* Intention to perform an isolated limb perfusion, instead of a tumor resection;\n* Neoadjuvant chemotherapy both before and after radiotherapy.",{"count":76,"type":21},150,[78],"NA","Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.",[81,82,26],"Sarcoma of Soft Tissue","Sarcoma",[84,85],"preoperative radiotherapy","radiotherapy","2026-02-16",{"date":88,"type":32},"2026-02-19",{"date":90,"type":32},"2025-12-11",{"date":92,"type":21},"2033-11-01",{"name":94,"class":38},"The Netherlands Cancer Institute",6,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100588608","colorectal-resections-in-patients-with-retroperitoneal-sarcoma-100588608","NCT06943612","Colorectal Resections in Patients With Retroperitoneal Sarcoma","Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life","COLOSARC-Q","Inclusion Criteria:\n\n* Histological confirmation with evidence of a retroperitoneal sarcoma\n* Tumor resection with colorectal resection\n* Surgery in a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria\n* Age 18 years or older\n* Written consent\n\nExclusion Criteria:\n\n* Absence of consent",{"count":105,"type":21},120,"COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of life.\n\nIn multivisceral resections involving the colon and rectum, the primary aim is to achieve complete resection and preserve organ function. However, multivisceral resections have a high risk of perioperative morbidity including anastomotic leakage. The proposed project aims to determine the number of primary anastomoses, their insufficiency rates, and the fraction of patients with primary and secondary stomas. In addition, the patients' quality of life after multivisceral sarcoma resection is to be recorded using standardized surveys.\n\nThe analysis has the potential to facilitate intraoperative decision-making for colorectal resections in the context of multivisceral resections.",[26,108],"Retroperitoneal Sarcoma",[110,108,111,112,113],"Soft tissue sarcoma","Sarcoma Surgery","Stoma","Colorectal resection","2025-12-04",{"date":116,"type":32},"2025-12-12",{"date":118,"type":32},"2025-01-27",{"date":120,"type":21},"2026-03",{"name":122,"class":38},"Heidelberg University",13,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":49,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":39},"100595051","phase-1-bold-100-plus-doxorubicin-in-advanced-soft-tissue-sarcomas-100595051","NCT07027423","BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas","A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas","Inclusion Criteria\n\n1. Written informed consent in accordance with federal, local, and institutional guidelines.\n2. Age \\> 18 years.\n3. Patients must have histologically confirmed locally advanced\u002Funresectable or metastatic soft tissue sarcoma of limited subtype LMS, DDLPS and UPS (including Myxofibrosarcoma-MFS).\n4. Patients be systemic treatment naïve, with incurable, advanced or metastatic disease.\n5. Patient must have measurable disease as defined by RECIST 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate hematopoietic function:\n\n   1. total white blood cell (WBC) count ≥2000\u002Fmm3.\n   2. absolute neutrophil count (ANC) ≥1500\u002Fmm3.\n   3. platelet count ≥100,000\u002Fmm3.\n8. Adequate hepatic function:\n\n   1. Bilirubin \\\u003C2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \\\u003C 3 times ULN).\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 X ULN. In the case of known (radiological and\u002For biopsy documented) liver metastasis, ALT\u002FAST \\\u003C5.0 X ULN is acceptable.\n9. Adequate renal function defined as \\\u003C1.5x upper limits of normal\n10. Cardiac function: A normal left ventricular ejection fraction (LVEF) of \\> 50% as evidenced by an echocardiogram or nuclear medicine study performed within 28 days of the proposed study commencement.\n11. Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at 72 hours prior to receiving the first dose of study medication. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.\n\nExclusion Criteria\n\nSubjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Patient is pregnant or lactating.\n2. Radiation (except planned or ongoing palliative radiation outside of the region of measurable disease), chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy.\n3. Major surgery within 4 weeks before initiation of therapy.\n4. Prior systemic therapy.\n5. Unstable cardiovascular function:\n\n   1. symptomatic ischemia, or.\n   2. uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmic is excluded and 1st degree AV block or asymptomatic LAFB\u002FRBBB will not be excluded) or.\n   3. congestive heart failure (CHF) of NYHA Class ≥3, or.\n   4. myocardial infarction (MI) within 3 months of initiation of therapy.\n6. Active, ongoing or uncontrolled active infection within one week prior to first dose.\n7. Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Prior chemotherapy is allowed apart from regimens that contained anthracycline based therapies.\n8. Known to be HIV seropositive.\n9. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg).\n10. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.\n11. Serious psychiatric or medical conditions that could interfere with treatment.\n12. Concurrent therapy with approved or investigational anticancer therapeutic agents.\n13. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results.",{"count":132,"type":21},32,[134],"PHASE1","A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.\n\nParticipants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg\u002Fm², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.\n\nParticipants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.\n\nUpon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.",[137,82,138,139],"Sarcoma, Soft-tissue","Sarcoma,Soft Tissue","Sarcomas","NOT_YET_RECRUITING","2025-11-27",{"date":143,"type":32},"2025-12-01",{"date":145,"type":21},"2026-03-30",{"date":147,"type":21},"2027-01-29",{"name":149,"class":38},"University Health Network, Toronto",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":49,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100583235","soft-tissue-sarcoma-motor-performance-robotic-rehabilitation-nutrition-and-quality-of-life-100583235","NCT06873685","Soft Tissue Sarcoma: Motor Performance, Robotic Rehabilitation, Nutrition, and Quality of Life","Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)","START-RUN1","Inclusion Criteria:\n\n1. patient with primary and localized STS who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection (including partial or complete resection of the iliopsoas muscle with functional loss and potential femoral nerve involvement) with curative intent;\n2. age 18 years or older.\n\nExclusion Criteria:\n\n1. recurrent tumors;\n2. metastatic disease;\n3. candidate for palliative and non-radical surgery;\n4. refusal to sign informed consent;\n5. Pregnant or breastfeeding women at the time of screening.",{"count":105,"type":21},[78],"Soft tissue sarcomas are a group of rare and heterogeneous tumors. Surgery is the mainstay of treatment and microscopic negative margins need to be achieved to improve disease local control. We designed this prospective study to evaluate the main features of motor impairment and the impact of tailored robotic rehabilitation techniques in patients treated for localized soft tissue sarcoma (surgery alone, or surgery + radiation or radiochemotherapy). Specific patients' motor strategies will be quantitatively measured through a biomechanical assessment, including the analysis of joint kinematics, and muscle activity timing patterns. Considering the influence of motor impairment after demolitive surgery, a major interest of this study will be focused on nutrition and Quality of life which will be prospectively evaluated by specific questionnaires at different time points.",[26],[163,164,165,166],"rehabilitation","nutrition","quality of life","instrumented assessment of motor performance","2025-03-19",{"date":169,"type":32},"2025-03-21",{"date":171,"type":32},"2025-03-13",{"date":173,"type":21},"2026-08-31",{"name":175,"class":38},"Fondazione Policlinico Universitario Campus Bio-Medico",3,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":49,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":39},"100558411","safety-and-efficacy-of-degradable-magnesium-metal-clips-in-surgical-margins-of-radical-surgery-for-malignant-bone-and-soft-tissue-tumors-100558411","NCT06550765","Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors","Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors: A Single-Center, Randomized Controlled Study","Inclusion Criteria:\n\n1. Participants must be of either gender, aged between 18 and 65 years;\n2. Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;\n3. Must have undergone standard chemotherapy and require en bloc resection;\n4. Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.\n\nExclusion Criteria:\n\n1. Severe dysfunction of the heart, liver, kidney, lung, or brain.\n2. Pregnant women or women who are breastfeeding.\n3. History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.\n4. History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.\n5. Participation in any other clinical study currently or within 3 months prior to the screening visit.\n6. Patients have any other conditions that the researcher deems unsuitable for the study. Age is between 18 to 75 years old.","65 Years",{"count":186,"type":21},98,[78],"To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.",[26,190],"Sarcoma, Spindle Cell",[192,193],"Soft Tissue sarcoma","biodegradable magnesium metal","2024-08-08",{"date":196,"type":32},"2024-08-13",{"date":198,"type":21},"2024-08-25",{"date":200,"type":21},"2027-12-31",{"name":202,"class":38},"Guangdong Provincial People's Hospital",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":49,"phases":213,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"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":212,"type":21},199,[134,51],"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.",[216,26,217,218,219],"Liposarcoma, Myxoid","Leiomyosarcoma","Liposarcoma","Pleomorphic Liposarcoma",[221],"sarcoma","2023-05-29",{"date":224,"type":32},"2023-05-31",{"date":226,"type":32},"2014-11",{"date":228,"type":21},"2028-06",{"name":230,"class":38},"Grupo Espanol de Investigacion en Sarcomas",17]