[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grupo Espanol de Investigacion en Sarcomas\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100450511","phase-1-multicohort-trial-of-different-schemes-of-pm14-in-monotherapy-and-in-combination-with-radiotherapy-in-soft-tissue-sarcomas-and-other-solid-tumor-100450511",false,"NCT05146440","Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor","Phase Ib\u002FII Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumors","PRIME","Inclusion Criteria:\n\nCohorts A, B, E, and F\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of soft tissue sarcoma with metastasis, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis confirmation will be performed and the tumor sample must be available and sent prior to inclusion to this end.\n4. A centralized diagnosis of DD liposarcoma or mixoid\u002Fhypercellular liposarcoma or leiomyosarcoma must be confirmed for patients in cohort E.\n5. A centralized diagnosis of other sarcomas includes: undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumors, sarcoma NOS, fibrosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, epithelioid sarcoma, clear cell sarcoma, dedifferentiated or aggressive features in solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, angiosarcoma, epithelioid hemangioendothelioma,\n6. Patients must have received a previous chemotherapy line in advanced disease unless contraindicated or not indicated.\n7. Radiological disease progression must be documented within 6 months prior to study entry.\n8. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed.\n9. Measurable disease according to RECIST v1.1 criteria.\n10. Performance status ≤1 (ECOG).\n11. Adequate bone marrow function (hemoglobin \\>10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients with creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 3.0 times the ULN, total bilirubin ≤ ULN, are acceptable.\n12. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.\n13. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n14. HBV and HCV serologies must be performed 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).\n15. Patient must have a central venous catheter for PM14 treatment.\n\nCohort C\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of advanced soft tissue sarcoma, or recurrent head \\& neck suitable for reirradiation or other advanced or metastatic solid tumor not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis will be performed and the tumor sample must be available and sent prior to inclusion to this end. For phase II part, onlysoft tissue sarcomas will be enrolled.\n4. Patients must have received a previous chemotherapy line in advanced disease.\n5. Disease distribution must allow meeting with normal tissue constrains of radiation therapy. Radiation oncologist must confirm this point at local sites.\n6. Metastatic spread could be present in several organs (i.e. lungs and pelvic fossa) however, not all the locations have to be irradiated.\n7. Those lesions considered for radiation therapy have to be related to symptoms (for phase II).\n8. It is allowed that not all the lesions will be under radiation fields. As a general rule, the priority is to select, as target-irradiating lesions, those with greater increase in size and those largest lesions if related with symptoms. Irradiating pulmonary lesions with infiltration of pleural serosa is discouraged.\n9. Radiological disease progression must be documented within 6 months prior to study entry.\n10. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced\u002Fmetastatic disease are allowed.\n11. The following histological subtypes can be included for the phase II part (central pathology review is mandatory before accrual): undifferentiated pleomorphic sarcoma (UPS), leiomyosarcoma, angiosarcoma, epithelial hemangioendothelioma, liposarcoma and its variants (well differentiated, dedifferentiated, myxoid\u002Fround cell, pleomorphic), synovial sarcoma, fibrosarcoma and its variants (epithelial fibrosarcoma\u002Flow grade fibromyxoid sarcoma), solitary fibrous tumor, malignant peripheral nerve sheath tumor (MPNST), myxofibrosarcoma, epithelioid sarcoma and (NOS) unclassified sarcoma.\n12. Measurable disease according to RECIST v1.1 criteria.\n13. Performance status ≤1 (ECOG).\n14. Adequate respiratory functions: FEV1 \\> 1L; DLco \\> 40% (patients with pulmonary target lesions).\n15. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients withcreatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.\n16. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.\n17. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.\n18. HBV and HCV serologies must be performed 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).\n19. Patient must have a central venous catheter for PM14 treatment.\n\nCohort D\n\n1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.\n2. Age: 18-75 years.\n3. Patients must have a diagnosis of localized soft tissue sarcoma that lacks one or more of the following risk criteria: G3, deep and \\> 5 cm. At least G2 is required (i.e. G3, superficial and \\> 5 cm; or G3 \\\u003C 5 cm deep; or G2, deep and \\> 5 cm, etc.).\n4. Patients must be diagnosed by core-biopsy and the elapsed time between biopsy and enrollment must be shorter than 6 weeks.\n5. Patients must be diagnosed by central pathology review with one of the following subtypes: leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, sarcoma NOS, fibrosarcoma, myxoid liposarcoma,dedifferentiated liposarcoma, solitary fibrous tumor (the formerly malignant subtype).\n6. Only those sarcomas of limbs or trunk wall will be eligible for this cohort.\n7. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point at local sites.\n8. Patients must have resectable primary tumor while it is allowed to enroll patients with metastatic spread that could be potentially resectable.\n9. Patients must have criteria of operability for the primary tumor.\n10. The patient must have been considered eligible for systemic chemotherapy.\n11. Measurable disease according to RECIST v1.1 criteria.\n12. Patients have to be candidates for MRI test.\n13. Performance status ≤ 1 (ECOG).\n14. Adequate bone marrow function (hemoglobin \\> 10 g\u002FdL, neutrophils ≥ 1,500\u002Fmm3, platelets ≥ 100,000\u002Fmm3). Patients withcreatinine clearance ≥ 30 mL\u002Fmin (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.\n15. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or 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 with PM14.\n\nExclusion Criteria:\n\nCohorts A, B, E, and F\n\n1. Performance status ≥ 2 (ECOG).\n2. Plasma bilirubin \\> ULN.\n3. Creatinine \\> 1.6 mg\u002FdL.\n4. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.\n5. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n6. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA).\n7. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n8. Uncontrolled bacterial, mycotic or viral infections.\n9. Women who are pregnant or breastfeeding.\n10. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.\n11. Patients participating in another clinical trial or receiving any other investigational product.\n12. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.\n13. Histologies other than those described in the inclusion criteria.\n\nCohort C\n\n1. Previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissue constrains).\n2. Performance status ≥ 2 (ECOG).\n3. Plasma bilirubin \\> ULN.\n4. Creatinine \\> 1.6 mg\u002FdL.\n5. History of other cancer with less than 5 years free of disease with the exception ofadequately treated basal cell carcinoma or in situ cervical cancer.\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 v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n9. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n10. Uncontrolled bacterial, mycotic or viral infections.\n11. Women who are pregnant or breastfeeding.\n12. Psychological, family, social or geographic circumstances that limit the patients' 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 D\n\n1. High-risk localized patients are not allowed to be enrolled (those G3, deep, and larger than 5 cm or those with risk of death at least 40% by sarculator nomogram).\n2. Previous treatment with radiotherapy.\n3. Primary tumor location other than those indicated in the inclusion criteria.\n4. Histological subtypes other than those indicated in the inclusion criteria.\n5. Unresectable or inoperable primary tumor.\n6. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.\n7. Performance status ≥ 2 (ECOG).\n8. Plasma bilirubin \\> ULN.\n9. Creatinine \\> 1.6 mg\u002FdL.\n10. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.\n11. Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA).\n12. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.\n13. Uncontrolled bacterial, mycotic or viral infections.\n14. Women who are pregnant or breastfeeding.\n15. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.\n16. Patients participating in another clinical trial or receiving any other investigational product.\n17. Patients who had participated in another clinical trial and\u002For had received any other investigational product in the last 30 days prior to inclusion.","ALL","18 Years","75 Years",{"count":21,"type":22},195,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Phase Ib\u002FII, multicohort, single arm, open-label, multicenter, international clinical trial, with 6 cohorts (advanced STS, advanced L-sarcomas, other advanced sarcomas, advanced solid tumors, and localized STS) with 4 sites in Spain for phase I.\n\nThe aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity profile in advanced soft tissue sarcoma patients as monotherapy and also in other solid tumors as concomitant treatment with radiation therapy.\n\nTreatment\n\nCohort A\n\nA phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 24-h IV infusion on day 1 of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.\n\nCohort B\n\nA phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 3-h IV infusion during 3 consecutive days (days 1-3) of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.\n\nCohort E\n\nPM14 will be administered at the recommended phase II dose (RP2D) according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.\n\nCohort F\n\nPM14 will be administered at the RP2D according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.\n\nCohort C\n\nPhase I: PM14 will be administered at the RP2D according to the most convenient scheme in 21-day cycles, at at different dose levels in combination with radiotherapy, up to progression or unacceptable toxicity. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation and during 2 additional days (in the 24-hour infusion) and during 3 additional days (in the 3-hour infusion). Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 3 Gy per fraction for 10 days (30 Gy in total).\n\nPhase II: PM14 will be administered at RP2D concomitant with radiation therapy.\n\nCohort D\n\nPhase I: PM14 will be administered at the RP2D according to the most convenient scheme, in up to 3 x 21-day cycles in neoadjuvant setting, at different dose levels in combination with radiotherapy. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 1.8 Gy per fraction for 25 days (45 Gy in total).\n\nPhase II: PM14 will be administered at RP2D concomitant with radiation therapy.",[29,30,31,32,33],"Advanced Soft-tissue Sarcoma","Advanced L-sarcomas","Other Advanced Sarcomas","Advanced Solid Tumor","Localized Soft-tissue Sarcoma","RECRUITING","2025-03-18",{"date":37,"type":38},"2025-03-21","ACTUAL",{"date":40,"type":38},"2021-11-23",{"date":42,"type":22},"2026-05-31",{"name":44,"class":45},"Grupo Espanol de Investigacion en Sarcomas","OTHER",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100376472","observational-study-for-quality-assessment-of-sarcoma-in-european-and-latin-american-multidisciplinary-network-100376472","NCT04181970","Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK","Observational Study, for Quality Assessment, of Sarcoma As a Model to Improve Diagnosis and Clinical Care of Rare Tumors Through a European and Latin American Multidisciplinary NETWORK","(SELNET)","Inclusion Criteria:\n\n* Histological diagnosis of soft-tissue sarcoma, GIST or bone sarcoma (all subtypes) from January 2005 until Juny\u002FSeptember 2023.\n* ≥ 18 years\n* Available clinical and treatment information\n\nExclusion Criteria:\n\nThere is no exclusion criteria","120 Years",{"count":57,"type":22},5000,"30 Months","OBSERVATIONAL","Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc.\n\nExpert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis.\n\nTumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.",[62,63,64],"Soft-tissue Sarcoma","Gastrointestinal Stromal Tumors","Bone Sarcoma",{"date":37,"type":38},{"date":67,"type":38},"2019-06-30",{"date":69,"type":22},"2026-09-30",{"name":44,"class":45},9,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"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":81,"type":22},199,[25,26],"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.",[85,86,87,88,89],"Liposarcoma, Myxoid","Sarcoma, Soft Tissue","Leiomyosarcoma","Liposarcoma","Pleomorphic Liposarcoma",[91],"sarcoma","2023-05-29",{"date":94,"type":38},"2023-05-31",{"date":96,"type":38},"2014-11",{"date":98,"type":22},"2028-06",{"name":44,"class":45},17,""]