[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maria Sklodowska-Curie National Research Institute of Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":330},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,74,108,131,151,177,207,236,258,283,304],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634942","optimal-radiotherapy---heel-spur-syndrome---randomized-clinical-trial-100634942",false,"NCT07546240","Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial","Impact of Total Dose and Fractionation on Clinical Outcomes of Low-Dose Radiotherapy for Heel Spur Syndrome: Optimal Radiotherapy - Heel Spur Syndrome (ORHEELS) Randomized Clinical Trial","ORHEELS","Inclusion Criteria:\n\n* Patients aged 40 years or older.\n* Clinically confirmed painful Heel Spur Syndrome (plantar fasciitis) persisting for at least 3 months\n* No effect from previous orthopaedic, physical, or analgesic treatments.\n* General performance status ZUBROD 0-3.\n* Exclusion of other local conditions.\n* Patient readiness for follow-up contact.\n\nExclusion Criteria:\n\n* Prior radiotherapy for heel spur.\n* Local use of corticosteroids within 4 weeks before planned radiotherapy.\n* Previous trauma, surgery to the foot on the same side.\n* Systemic diseases (eg collagen vascular disease).\n* Pregnancy or breastfeeding.\n* Lack of written informed consent","ALL","40 Years",{"count":20,"type":21},366,"ESTIMATED","INTERVENTIONAL",[24],"NA","Heel Spur Syndrome (HSS), is a pathology characterized by chronic inflammation and degenerative changes that affect approximately 10% of adults. Although many patients respond to conservative care, about 30% experience persistent pain. Low-dose radiation therapy (LDRT) is a well-established European method with proven anti-inflammatory and immunomodulatory effects. The ORHEELS trial aims to assess whether a Polish standard dose of 6 Gy in 6 daily fractions (fx)(5 times\u002Fweek) is not inferior to the treatment with total dose of 3 Gy \u002F fx 0,5 Gy \u002Ffractionated twice weekly. The study is designed to assess the impact of intensity of treatment (daily (5 times \u002F week) versus twice weekly fractionation) on clinical outcomes.",[27],"Heel Spur Syndrome",[29,30,31,32],"Heel spur","Plantar fasciitis","Low-dose radiotherapy","Anti-inflammatory radiotherapy","RECRUITING","2026-04-16",{"date":36,"type":37},"2026-04-22","ACTUAL",{"date":39,"type":37},"2026-03-23",{"date":41,"type":21},"2030-03-22",{"name":43,"class":44},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100609559","noseal-trial-comparing-sealants-versus-no-sealant-for-preventing-csf-leak-after-endonasal-skull-base-surgery-100609559","NCT07216157","NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery","The NoSeal Trial - Nasal Outcome Study Evaluating Artificial Leak-Sealing: A Prospective, Randomized, Controlled, Single-Blinded, Single-Center Clinical Trial Comparing Fibrin Glue (Tisseel®) and a Two-Component Synthetic Polymer Sealant (PEI\u002FPEG, Adherus®) Versus No Sealant for the Prevention of Cerebrospinal Fluid Leak and Promotion of Wound Healing Following Endonasal Skull Base Surgery, Designed in Accordance With the SPIRIT 2025 Guidelines","NoSeal","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction\n* Informed written consent obtained prior to enrollment\n* Hemodynamic and electrolyte stability before surgery\n* Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques\n\nExclusion Criteria:\n\n* Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)\n* Tumors requiring complex sella reconstruction from the start\n* Preoperative hydrocephalus\n* Known allergy to fibrin-based or synthetic sealant components\n* Active sinus infection or systemic inflammatory disease\n* Prior radiotherapy to the sellar or parasellar region\n* Uncontrolled diabetes mellitus (HbA1c \\> 7.0%)\n* Participation in another interventional trial that may influence wound healing or CSF assessment\n* Radiologic signs of chronic intracranial hypertension or hypotension","18 Years",{"count":56,"type":21},225,[24],"Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI\u002FPEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.",[60],"CerebroSpinal Fluid (CSF) Leak",[62,63,64,65],"csf","pituitary adenoma","csf leak","sealant","2025-10-09",{"date":68,"type":37},"2025-10-14",{"date":70,"type":37},"2025-08-15",{"date":72,"type":21},"2027-03-15",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100591099","phase-2-immune-pet-and-proteomics-for-the-assessment-of-response-to-spatially-fractionated-or-palliative-radiotherapy-with-or-without-immunotherapy-100591099","NCT06976021","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy","Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych","INTROSPECTION","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.\n2. Patients nnot eligible for radical treatment with radiotherapy (including stereotactic radiotherapy of the tumor in the potential planned area of irradiation in the study), chemotherapy and palliative immunotherapy in accordance with applicable national standards but who qualify for palliative radiation treatment\n3. General condition according to Karnofsky scale: 60-100\n4. Patients with tumor (index lesion) larger than 5 cm in size that can be irradiated with either SHORT or SFRT technique (presence of other tumors that may be independently treated locally is not an exclusion criterion)\n5. The tumor may be assessed using iRECIST\n6. Age over 18 years\n7. Granted written, informed consent to participate in the research experiment\n8. No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).\n9. Expected survival time over 6 months.\n\nExclusion criteria\n\n1. Lack of consent to participate in the experiment\n2. Contraindications to Pembrolizumab according to the product characteristics\n3. Pregnancy and lactation\n4. Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.\n5. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout treatment and for 5 months after its completion.\n6. Condition after organ transplantation",{"count":83,"type":21},60,[85],"PHASE2","The aim of the study is to evaluate the response to four schemes of treatment with novel diagnostic tools - Immuno-PET and proteomics as well as standard imaging (magnetic resonsonce imaging and computed tomography). Two fractionation schedules of radiotherapy will be used. The first will be a common standard of palliative irradiation - 20 Gy delivered in five fractions of 4 Gy (SHORT). The other is called Spatially Fractionated Radiotherapy (SFRT). SFRT is delivered in one fraction of 20 Gy but the dose is diversified inside the tumor to produce areas of high and low doses distributed alternately. This kind of irradiation may be able to stimulate immune response and improve the efficiency of immunotherapy. A drug belonging to the class of immunotherapeutic agents - Pembrolizumab will be added to the treatment scheme in two arms of the study to check that assumption. The response of the target tumor will be evaluated with PET study using Pembrolizumab labeled with zirconium-89 which will show the spatial distribution of immune receptors within the target tumor and other involved sites if there are any. The examination will be repeated after the treatment to evaluate changes in distribution of the immune receptors necessary for the drug to work. Additionally, the researchers will repeatedly test the presence and concentration of a wide panel of proteins in blood to evaluate response to the treatment more precisely.",[88,89,90,91,92],"Triple Negative Breast Cancer","Uterine Cervical Cancer","Uterine Corpus Cancer","Malignant Melanoma","Clear Cell Renal Cell Carcinoma",[94,95,96,97,98],"spatially fractionated radiotherapy","immunotherapy","immuno-PET","proteomics","signaling pathways","NOT_YET_RECRUITING","2025-05-08",{"date":102,"type":37},"2025-05-16",{"date":104,"type":21},"2025-06",{"date":106,"type":21},"2029-12",{"name":43,"class":44},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100433195","phase-2-obinutuzumab-versus-rituximab-for-acute-lymphoblastic-leukemiapalg-all7-overall-100433195","NCT04920968","Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia\u002FPALG ALL7 \"OVERALL\"","Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia","OVERALL","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.\n3. Signed written informed consent.\n4. Adequate contraception in case of women with child-bearing potential\n\nExclusion Criteria:\n\n1. Lymphoblastic lymphoma with bone marrow blasts\\\u003C20%.\n2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.\n3. Major surgery within 4 weeks before enrollment.\n4. Impaired cardiac function: ejection fraction \\\u003C40% on echocardiography, QTc interval \\> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).\n5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus\n6. Other concurrent severe and\u002For uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and\u002For life-threatening medical disease.\n7. Serum creatinine \\> 2 times the upper normal limit of the laboratory, total bilirubin\\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \\> 5 upper normal limit, unless related to Acute lymphoblastic leukemia\n8. Intolerance to treatment with monoclonal antibody.\n9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.\n10. Inability to obtain written informed consent.\n11. Inability to comply with regular monitoring.",{"count":117,"type":21},124,[85],"A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).",[121],"CD20-positive Acute Lymphoblastic Leukemia","2025-04-21",{"date":124,"type":37},"2025-04-24",{"date":126,"type":37},"2021-10-05",{"date":128,"type":21},"2025-12-31",{"name":43,"class":44},19,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":150},"100429710","phase-2-nivolumab-in-nasopharyngeal-cancer-with-progression-during-or-after-platinum-based-treatment-100429710","NCT04875611","Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment","Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy","NIVONASO-21","Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Histological or cytological documentation of squamous cell carcinoma.\n3. Primary tumor location in nasopharynx\n4. Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy\n5. Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy\n6. ECOG(Eastern Cooperative Oncology Group) performance scale 0-1\n7. Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures.\n\nExclusion Criteria:\n\n1. Known active central nervous system metastases.\n2. Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \\\u003C 30 ml\u002Fmin\u002Fm2\n3. Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and \u002For ALT(alanine aminotransferase) \\> 2,5 x ULN(upper limits of normal) (\\> 5 x ULN in patients with documented liver metastases); total bilirubin \\> 1,5 xULN ( bilirubin \\> 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\\u003C 35%) or albumin \\\u003C 2,5 g\u002FdL\n4. Abnormalities in blood count such as: hemoglobin \\\u003C 9 g\u002Fdl, platelets \\\u003C 100 x 109 \u002FL, Absolute Neutrophil Count (ANC) \\\u003C1,0 x 109 \u002FL\n5. Ejection fraction in echocardiography \\\u003C 50%\n6. History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.\n7. Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.\n8. Pregnancy or breastfeeding.\n9. Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)\n10. Prior therapy with an anti-PD-1\u002FL1\u002FL2 and\u002For anti-ICOS directed agent\n11. Patient is currently participating in another clinical trial.\n12. Active infection, which significantly affects the patient's clinical condition and requires treatment.\n13. Patient with prior bone marrow or solid organ transplantation.\n14. Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \\> 10 mg)\n15. Known immunodeficiency including HIV\u002FAIDS(human immunodeficiency virus\u002Facquired immunodeficiency syndrome) infection.\n16. Patient received any live vaccine within 28 days before enrollment.\n17. Heart Failure - NYHA(New York Heart Association functional classification system) III or IV\n18. Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period \\> 2 years, except: cervical cancer in situ\u002F basocellular skin cancer\u002Fprostate cancer, after radical treatment.\n19. Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.",{"count":140,"type":21},32,[85],"Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.",[144],"Nasopharyngeal Cancer",{"date":124,"type":37},{"date":147,"type":37},"2021-08-26",{"date":128,"type":21},{"name":43,"class":44},4,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":150},"100482548","phase-2-pembrolizumab-in-the-treatment-of-advanced-progressive-adrenocortical-carcinoma-100482548","NCT05563467","Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.","A Multicentre, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.","PEMBR-01","Inclusion Criteria:\n\n1. Signing the informed consent form to participate in the study\n2. Age over 18 years of age\n3. Histopathologically confirmed adrenocortical carcinoma\n4. The general condition of the patient was assessed according to the Eastern Cooperative Oncology Group (ECOG) scale \\\u003C2\n5. Measurable disease according to RECIST 1.1\n6. Confirmed progression according to RECIST 1.1 within the last 6 months in patients, who received at least one line chemotherapy according to the EDP or EDP-M\n7. Adequate function of the marrow and internal organs:\n\n   1. hemoglobin ≥ 9g%, neutrophils\\> 1500 \u002F mm3, platelets\\> 100 thousand \u002F mm3\n   2. bilirubin ≤ 2 x upper limit of normal (UNL), Alat, Aspat ≤ 3 x UNL (if livermetastases are present ≤ 5 x UNL)\n   3. creatinine clearance \\> 40 ml \u002F min\n   4. coagulation parameters: INR, PT, APTT \\\u003C1.5 x UNL (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for the patient)\n8. For women of reproductive age : confirmed negative pregnancy test result, and the requirement of dual barrier contraception\n9. For men of reproductive age: the requirement of dual barrier contraception\n\nExclusion Criteria:\n\n1. Pre-treatment with an immune checkpoint inhibitor\n2. Any cancer therapy within the last 7 days (including mitotane)\n3. Persistent side effects of previous anti-cancer therapy in the\\> G1 stage or after surgical treatment (exception: alopecia)\n4. Immunosuppressive therapy present or conducted within the last 4 weeks\n5. Glucocorticoid therapy in a dose higher than the replacement dose (subject to the permitted use: inhaled or topical steroids, single administration of a steroid, e.g. in case of an allergic reaction to contrast, use of mineralocorticosteroids, steroids in the course of asthma or COPD)\n6. Previous allograft marrow or organ transplant\n7. Current or diagnosed in the last 2 years autoimmune disease with the exception of vitiligo, psoriasis not requiring systemic treatment, autoimmune disease of the thyroid gland\n8. Active or previously documented inflammatory disease of the large intestine\n9. Previous non-infectious pneumonia requiring steroid therapy\n10. Hepatitis B or C\n11. Active tuberculosis\n12. Current active infection requiring systemic treatment\n13. Symptomatic, untreated central nervous system (CNS) metastases (exception: patients with asymptomatic CNS metastases with prior surgery or radiotherapy and no history of intracranial bleeding)\n14. Circulatory failure NYHA ≥3\n15. Corrected QT interval\\> 500 ms\n16. Significant coexisting disease, including neoplastic, except for basal cell carcinoma of the skin, carcinoma in situ: prostate, cervix, breast\n17. Other significant comorbid disease that, in the investigator's opinion, would pose risks to the patient during therapy\n18. Pregnancy or breastfeeding\n19. Patients requiring dialysis\n20. The patient's inability to meet the requirements specified in the study protocol\n21. Vaccination with live vaccine within 3 months before starting treatment",{"count":160,"type":21},24,[85],"This study is a national, multicenter, interventional, phase II clinical trial on the use of pembrolizumab in advanced adrenocortical carcinoma, with confirmed progression within 6 months, following EDP or EDP-M ( etoposide, doxorubicin, cisplatin- mitotan) chemotherapy.\n\nAdrenocortical carcinoma is a very rare entity with poor prognosis and limited therapeutic options. Only radical surgical treatment of the early stages gives a chance for complete cure, however the risk of recurrence still remains high.\n\nThe results of clinical trials conducted outside Poland indicate a possible potential role of immunotherapy as a rescue treatment for adrenocortical carcinoma after standard therapeutic methods have been exhausted.\n\nThis study will evaluate the efficacy and tolerability of treatment with the immune checkpoint inhibitor pembrolizumab in locally advanced, non-operable or metastatic adrenocortical carcinoma after first line chemotherapy failure.\n\nThe study population will include adult patients (\\>18 years of age) with histopathologically confirmed adrenocortical carcinoma and confirmed progression according to RECIST 1.1 within 6 months, after first line chemotherapy with the EDP and EDP-M scheme. Patients must meet the inclusion criteria and must not meet the exclusion criteria described in the PEMBR-01 study protocol. The planned number of patients in the study is 24.\n\nThe treatment regimen will be based on Pembrolizumab administered intravenously in 3 weeks cycles at a dose of 200mg. For hormonally active tumors producing cortisol, it is hypothesized that the use of pembrolizumab in combination with effective steroidogenesis inhibition may enhance the effect of immunotherapy. In the study, metyrapone or ketoconazole will be used for this purpose.\n\nThe primary endpoint of the study will be the objective response rate to the treatment. The secondary endpoints will be progression-free survival, duration of response, overall survival, and treatment safety as well as the effect of therapy on patients' quality of life.\n\nConcurrently, the analysis of biomarkers in tumor tissue will be carried out, including tumour infiltrating lymphocytes, expression of programmed death ligand, microsatellite instability and tumour mutation burden.",[164],"Adrenocortical Carcinoma",[166,167,168],"advanced adrenocortical carcinoma","progressive adrenocortical carcinoma","pembrolizumab","2025-03-28",{"date":171,"type":37},"2025-04-02",{"date":173,"type":37},"2023-01-31",{"date":175,"type":21},"2027-05-31",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":185,"minAge":54,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100531536","phase-2-stereotactic-re-irradiation-of-local-recurrences-of-prostate-cancer-after-radiotherapy-100531536","NCT06201078","Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy","Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial","PROSTARE","Inclusion Criteria:\n\n1. Local recurrence of prostate cancer after definitive radiotherapy\n\n   1. biopsy proven or\u002Fand\n   2. Consistent MRI and PET-PSMA results and PSA growth dynamics\n2. Time since primary radiotherapy - at least 2 years\n3. Good performance status (ZUBROD 0-1)\n\n   * If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence.\n\nExclusion Criteria:\n\n1. Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)\n2. Tumour volume (GTV) \\> 14 cc\n3. Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation\n4. Severe dysuria before repeated SBRT (e.g., IPSS ≥19)\n5. Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)\n6. Previous prostate brachytherapy\n7. Substantial risk for further urologic interventions (e.g., TURB\u002FTURP)","MALE","80 Years",{"count":188,"type":21},55,[85],"The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy.\n\nThe main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control with other secondary endpoints which include: Biochemical Response, Biochemical Failure-Free Survival, Metastases-Free Survival, Relapse-Free Survial, Local Control, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25).\n\nThe evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated\u002Fmoderately hypofractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B).\n\nThe study group is planned to include 55 patients.",[192,193],"Local Recurrence of Malignant Tumor of Prostate","Radiotherapy",[195,196,197,198],"local recurrence","prostate","radiotherapy","salvage","2025-03-10",{"date":201,"type":37},"2025-03-13",{"date":203,"type":37},"2023-07-31",{"date":205,"type":21},"2029-12-31",{"name":43,"class":44},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":45},"100579254","phase-2-stereotactic-radiosurgery-in-the-treatment-of-essential-tremor-100579254","NCT06821906","Stereotactic Radiosurgery in the Treatment of Essential Tremor","Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study","EASIER","Inclusion Criteria:\n\n* Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded.\n* Insufficient tremor control despite the use of available pharmacotherapy methods.\n* Disqualification from the Deeply Brain Stimualtion procedure\u002Flack of consent to perform it on the side qualified for Stereotactic Radiosurgery\n* Consent to participate in a clinical trial.\n\nExclusion Criteria:\n\n* Age under 50\n* Pregnancy\n* Duration of the disease less than 5 years\n* Dementia, psychosis or other condition that prevents giving informed consent to participate in the study\n* Poor general condition, serious comorbidities\n* Structural changes in the basal ganglia or major atrophic changes\n* Previous radiotherapy to the brain covering the potential treatment area\n* Medical contraindications to magnetic resonance imaging","50 Years",{"count":217,"type":21},42,[85],"The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients",[221],"Essential Tremor",[223,224,225,226,227],"tremor","stereotactic radiosurgery","frameless radiosurgery","essenstial tremor","CyberKnife","2025-02-06",{"date":230,"type":37},"2025-02-12",{"date":232,"type":37},"2024-12-16",{"date":234,"type":21},"2030-05",{"name":43,"class":44},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":185,"minAge":54,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":45},"100550646","phase-2-177lu-psma-as-a-systemic-adjuvant-treatment-in-patients-with-high-and-very-high-risk-prostate-cancer-100550646","NCT06449781","177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer","177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy","PSMA-ADJUVO","Inclusion Criteria:\n\n* Giving a written informed consent\n* Histopathologically confirmed high or very high risk prostate cancer\n* Completion of radical locoregional treatment\n* Completion of locoregional treatment within 3 months before inclusion to the study\n* ECOG performance status 0 to 2\n* Age over 18 years\n* Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests\n* Castrate testosterone level (testosteron \\\u003C 50 ng\u002FdL lub 1,7 nmol\u002FL)\n* Patients with adequate function of main organs:\n\n  * bone marrow:\n\n    * neutrophils \\> 1500x10\\^9\u002FL;\n    * thrombocytes \\> 100,000x10\\^9\u002FL;\n    * hemoglobin \\> 9 g\u002FdL\n  * liver:\n\n    * bilirubin \\\u003C 2xULN (upper limit of normal) in patients with Gilbert's syndrome \\\u003C 5xULN;\n    * aminotransferase \\\u003C 3xULN\n  * kidneys:\n\n    * eGFR \\> 50 ml\u002Fmin\n    * albumin \\>2.5 mg\u002Fml\n* For men of reproductive age: the need to use double barrier contraception\n\nExclusion Criteria:\n\n* The presence of distant metastases confirmed by radiological examination\n* Absence of approval to use effective contraception method\n* Absence of Patient's consent to participate in the Study\n* Urinary tract obstruction or\u002Fand hydronephrosis.\n* Concurrent anticancer treatment.",{"count":245,"type":21},200,[85],"Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy",[249],"Prostate Cancer","2025-02-05",{"date":252,"type":37},"2025-02-10",{"date":254,"type":37},"2025-01-09",{"date":256,"type":21},"2030-11",{"name":43,"class":44},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":186,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":45},"100552398","stereotactic-radiosurgery-in-patients-with-head-and-neck-region-tumours-100552398","NCT06472570","Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours","Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours","Inclusion Criteria:\n\n1. Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H\\&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.\n2. Patients with other malignant tumours of the H\\&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.\n3. Patients with nonmalignant tumours of the H\\&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.\n4. Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12\n5. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n6. Conscious agreement to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Do not meet the inclusion criteria.\n2. Decompensated diabetes mellitus.\n3. Myocardial infarction occurred up to 6 months before.\n4. Pregnancy.\n5. Mental disorder preclusive of making a conscious agreement",{"count":266,"type":21},80,[24],"The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\\&N tumours.",[270],"Head and Neck Cancer",[272,273,274],"stereotactic radiotherapy","radiosurgery boost","head and neck cancer","2024-06-24",{"date":277,"type":37},"2024-06-25",{"date":279,"type":37},"2019-10-26",{"date":281,"type":21},"2030-12-31",{"name":43,"class":44},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":291,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":45},"100552399","phase-2-preoperative-immunotherapy-combined-with-stereotactic-radiation-therapy-boost-in-the-treatment-of-her2-negative-breast-cancer-100552399","NCT06472583","Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer","A Phase II Study of Preoperative Stereotactic Radiation Therapy Boost Combined With Short-course Immunotherapy (Pembrolizumab Versus Placebo, Randomized, Double-blind) and Standard Chemiotherapy in Patients With Newly Diagnosed HER2-negative Nonmetastatic Breast Cancer With Lack of Early Metabolic Response in 18- fluorodeoxyglucoseFDG-PET\u002FCT After 1st Chemoterapy Cycle","BREAST-BOOSTER","Inclusion Criteria:\n\n* A woman or a man over 18 years of age.\n* Diagnosis of invasive breast cancer\n* Patient eligible for standard preoperative chemotherapy for breast cancer with anthracyclines and paclitaxel, according to the investigator's assessment\n* Breast cancer stage:\n\n  * any T cN1-cN3\n  * cT4 any N (stages IIA\u002FIIB\u002FIII\u002FIV, excluding cT1-3 N0 patients).\n  * Oligometastatic disease is allowed (stage IV, up to 3 foci in one organ or 2 foci in total in 2 different organs), if radical treatment using local methods is possible, both in the treatment of the primary tumor and in the treatment of the metastatic focus (radiotherapy, surgery). Patients with distant metastases who do not qualify for radical treatment cannot be included.\n* Cancer without estrogen receptor expression (ER\\\u003C1% and PR\\\u003C1%) or luminal cancer\n* HER2-negative cancer\n* Definitely multifocal or multicentric tumors are acceptable if HER2 negative status is confirmed in all identified invasive tumor foci; this is not required in the case of satellite lesions adjacent to the tumor mass or small lesions less than 1 cm in diameter identified in MRI\n* No prior chemotherapy for a current diagnosis of breast cancer and no prior anthracycline chemotherapy for any reason; earlier preoperative hormone therapy is allowed if, in the investigator's opinion, the patient requires the initiation of chemotherapy; patients may be included after 1 cycle of AC chemotherapy (1 administration) if the patient underwent a PET\u002FCT (Positron Emission Tomography and Computed Tomography) scan using 18-FDG before starting treatment\n* Any oncological treatment for another cancer is acceptable if it was radical, ended at least 1 year before inclusion in the study and did not include radiotherapy in the chest area on the same side as the currently treated breast cancer\n* There are no contraindications to radiation treatment\n* ECOG PS (Eastern Cooperative Oncology Group Performance Status) status 0 or 1\n* Bone marrow function confirmed by hemoglobin concentration ≥9 g\u002FdL and neutrophil count (ANC) ≥1500\u002FμL and PLT (platelets) count ≥100,000\u002FμL\n* Bilirubin concentration ≤ 1.5 x upper limit of normal (ULN), except for patients with a diagnosis of Gilbert's syndrome confirmed by previous measurements or another method (then direct bilirubin ≤ ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity ≤ 3 x ULN\n* Creatinine concentration ≤ ULN or creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault method in patients with creatinine concentration above the upper limit of normal\n* Left ventricular ejection fraction EF ≥ 50%\n* No contraindications to breast magnetic resonance imaging (MRI)\n* In patients with reproductive potential: consent to implement adequate contraceptive methods before enrollment in the study, during therapy and for at least 6 months after the end of systemic treatment\n* Giving informed written consent to participate in the study\n\nExclusion Criteria:\n\n* Inflammatory breast cancer (cT4d)\n* Hypersensitivity to drugs or excipients used in the study, which, in the opinion of the researcher, does not allow therapy to be initiated\n* Major surgical or medical procedure within 14 days prior to study entry; does not apply to ovariectomy performed laparoscopically, including as a risk-reducing surgical procedure and ovarian biopsy as a fertility preservation procedure and diagnostic procedures\n* Parallel coexisting invasive cancer\n* Co-existing known HIV (human immunodeficiency virus) infection, known active HBV (hepatitis B virus) or HCV (hepatitis C virus) infection\n* Diagnosed autoimmune disease requiring immunosuppressive therapy; does not apply to thyroid diseases if, in the opinion of the endocrinologist, they are not a contraindication to pembrolizumab therapy\n* Any disease requiring systemic steroid therapy within 3 weeks before enrollment in the study\n* Serious, uncontrolled mental illness\n* Condition after organ allotransplantation\n* Condition after implantation of devices that do not allow breast MRI examination (does not apply to examinations with the assistance of a cardiologist, if the patient qualifies for such a procedure);\n* Pregnancy or breastfeeding\n* Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or drugs targeting other T cell receptor inhibitors\n* History of non-infectious pneumonia requiring steroid therapy or current pneumonia\n* Active infection requiring systemic treatment\n* Significant cardiovascular disease, such as acute coronary syndrome within the last 6 months,\n* History of active tuberculosis\n* Other criteria, comorbidities, conditions, therapies, laboratory abnormalities, or circumstances that, in the investigator's opinion, do not allow the study procedures to be safely performed, may interfere with the study results, or may substantially impair patient compliance",true,{"count":293,"type":21},78,[85],"The goal of the study is to assess the safety and effectiveness of the combination of anti-PD1 immunotherapy (pembrolizumab) and radiotherapy in the preoperative treatment of HER2-negative breast cancer resistant to classical chemotherapy.\n\nThe subject of the intervention will be:\n\n1. Randomly assigned in a 2:1 ratio and double-blinded addition of pre-operative immunotherapy with pembrolizumab or placebo to standard chemotherapy\n2. Addition of preoperative radiotherapy boost delivered with a CyberKnife radiosurgery system concomitantly with the use of paclitaxel (+\u002F- carboplatin) and pembrolizumab \u002F placebo.",[297],"Breast Cancer",{"date":277,"type":37},{"date":300,"type":37},"2024-04-11",{"date":302,"type":21},"2028-02-28",{"name":43,"class":44},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":311,"targetDuration":313,"studyType":314,"phases":4,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":45},"100445453","analysis-of-prevalence-and-risk-factors-associated-with-gastroesophageal-reflux-disease-and-esophagitis-after-peroral-endoscopic-myotomy-100445453","NCT05080634","Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy","Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy","Inclusion Criteria:\n\n1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)\n2. Achalasia patients who underwent POEM\n\nExclusion Criteria:\n\n1. Lack of written consent for participation in the study\n2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry",{"count":312,"type":21},100,"5 Years","OBSERVATIONAL","Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.",[317,318],"Achalasia","GERD",[320,321],"Peroral endoscopic myotomy","High-resolution esophageal manometry","2021-10-04",{"date":324,"type":37},"2021-10-18",{"date":326,"type":37},"2021-06-01",{"date":328,"type":21},"2026-09-01",{"name":43,"class":44},""]