[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiotherapy-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiotherapy-complications":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,46,71,98,125,150,174,208,238,262,288,322,349,372,412,437,466,496],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100482407","phase-2-radiotherapy-by-sonic-hedgehog-pathway-inhibitors-in-basal-cell-carcinoma-100482407",false,"NCT05561634","Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma","Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study","RADIOSONIC","Inclusion Criteria:\n\n* Patient over 18 years\n* Locally advanced non-recurrent BCC in complete response after first course of SHHi\n* Complete response has to be confirmed histologically\n* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor\n\nExclusion Criteria:\n\n* Patients with distant metastasis\n* Patients with Gorlin's syndrome\n* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields\n* Pregnant women\n* Life expectancy less than 1 year\n* Inability to receive informed consent\n* Inability to participate in the entire study\n* Lack of social security coverage\n* Refusal to sign consent","ALL","18 Years",{"count":20,"type":21},82,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a \"consolidation radiotherapy\" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.",[27,28],"Basal Cell Carcinoma","Radiotherapy; Complications",[30,31,32],"Locally advanced basal cell carcinoma","Sonic Hedgehog inhibitors","Consideration radiotherapy","RECRUITING","2025-09-24",{"date":36,"type":37},"2025-09-30","ACTUAL",{"date":39,"type":37},"2023-06-20",{"date":41,"type":21},"2029-06-20",{"name":43,"class":44},"University Hospital, Lille","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100450795","radiotherapy-or-observation-of-liver-metastases-in-small-cell-lung-cancer-100450795","NCT05150145","Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer","A Prospective Phase II Randomized Clinical Study of Radiotherapy or Observation of Liver Metastases for Small Cell Lung Cancer.","Inclusion Criteria\n\n1. Informed consent (radiation, medication) before treatment;\n2. Age 18 to 70 years old,regardless of gender;\n3. Initial SCLC confirmed by histopathological or cytological examination;\n4. Metastatic lesions in the distant area: included liver metastasis；\n5. Physical status score ECOG: 0 to 2；\n6. The expected survival time is more than 3 months;\n7. Bone marrow function:hemoglobin(HGB)\\>90g\u002FL,platelet(PLT)\\>100×109\u002FL,neutrophil cell(WBC)\\>1.5×109\u002FL(\\*normal value);\n8. Liver function:alanine aminotransferase(ALT) and aspertate aminotransferase(AST)\\\u003C1.5 times of the upper limit of normal(ULN);Total bilirubin \\\u003C1.5ULN;\n9. Renal function:Serum creatinine was lower than 1.5ULN,and the endogenous creatinine clearance rate(Ccr) is higher than 55mL\u002Fmin;\n10. Initial treatment (previously did not receive any thoracic radiotherapy or surgery).\n\nExclusion Criteria:\n\n1. patients with history of mental illness;\n2. patients combined with other malignancies;\n3. Active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy;\n4. Patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias.\n5. Patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors.\n6. History of hepatitis and cirrhosisi ;\n7. pregnant, lactating patients;\n8. Patients with poor compliance；\n9. Researchers believe that it is not appropriate to participate in this test.","70 Years",{"count":55,"type":21},66,[57],"NA","The aim of this randomized study is to investigate local tumor control,survival outcomes and complications on patients of liver metastasis in small cell lung cancer.",[28],[61],"Radiotherapy;liver metastases;Small cell lung cancer;","2025-06-22",{"date":64,"type":37},"2025-06-26",{"date":66,"type":37},"2021-04-30",{"date":68,"type":21},"2026-03-01",{"name":70,"class":44},"Guizhou Medical University",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100591595","high-dose-rate-hdr-brachytherapy-salvage-after-prostatectomy-100591595","NCT06982469","High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy","Magnetic Resonance Imaging (MRI)\u002F Positron Emission Tomography (PET) Prostate-specific Membrane Antigen (PSMA) -Based Phase I-II Study of Salvage HDR Brachytherapy and External Beam Irradiation In Isolated Tumor Bed Relapses After Radical Prostatectomy","Inclusion Criteria:\n\n* Patients with increasing PSA after RP and clinical evidence of PET PSMA\u002FCholine+ and MRI+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.\n* Pathological confirmation is advised in all cases but it is not mandatory .\n* Brachytherapy MRI-based dosimetry\n* Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.\n\nExclusion Criteria:\n\n* Distant Metastases\n* Isolated nodal relapses\n* Prior Irradiation to the IPBR area\n* Multicentric IPBRs\n* Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure","MALE","80 Years",{"count":81,"type":21},20,"OBSERVATIONAL","The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy. The main question it aims to answer is:\n\nDoes HDR Brachytherapy increase control rates and decreases complications compared with conventional External Irradiation?\n\nParticipants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy",[85,86,87,28,88],"Prostate Cancer","Prostatectomy","Local Recurrence of Malignant Tumor of Prostate","Brachytherapy","2025-06-18",{"date":91,"type":37},"2025-06-19",{"date":93,"type":37},"2020-05-05",{"date":95,"type":21},"2030-05-01",{"name":97,"class":44},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":45},"100492774","stereotactic-ablative-radiotherapy-for-the-treatment-of-refractory-ventricular-tachycardia-100492774","NCT05696522","Stereotactic Ablative Radiotherapy for the Treatment of Refractory Ventricular Tachycardia","SABRE-VT","Inclusion Criteria:\n\n1. They are at least 18-85 years old.\n2. They have recurrent VT (at least three episodes in the preceding six months) requiring therapy from an ICD, that is refractory to conventional treatments - both maximally tolerated doses of anti- arrhythmic drugs and\u002For conventional catheter ablation.\n3. They are too frail or do not wish to undergo conventional catheter ablation.\n4. They have not had previous radiotherapy to the anticipated treatment field.\n\nExclusion Criteria:\n\n1. They have polymorphic VT or ventricular fibrillation (VF).\n2. They have inotrope-dependent heart failure or a left ventricular assist device (LVAD) in situ.\n3. They are unlikely to live more than 12 months irrespective of the VT.\n4. There is a potentially reversible cause for the VT e.g. critical coronary artery disease or a metabolic problem such as an overactive thyroid gland.\n5. They are unable to provide informed consent.\n6. They have had previous radiotherapy to the anticipated treatment field.\n7. The patient weighs in excess of 170kg (maximum weight capacity of the tables in the imaging department).","85 Years",{"count":107,"type":21},6,[57],"Ventricular tachycardia (VT) is an abnormal rhythm arising from the bottom chambers (ventricles) of the heart. The hearts of most patients who develop VT have been previously damaged by a myocardial infarction (heart attack) or other heart muscle diseases (cardiomyopathies). The damage produces scar or fatty deposits that conduct electrical impulses slowly allowing VT to occur. Recurrent episodes of VT can compromise heart function and increase mortality.\n\nVT is prevented by special drugs but these are not always effective and can have many side effects. Most patients with VT will also have a specialised device called an implantable defibrillator (ICD) implanted. The ICD treats VT by either stimulating the heart rapidly or delivering a shock to it. ICDs are very effective but the shocks are painful and have a big impact on quality of life. If VT occurs despite optimal drug treatment, patients undergo an invasive procedure called catheter ablation. Here, wires are passed into the heart from the blood vessels in the leg and the damaged heart muscle causing the VT is identified whilst the heart is in VT. An electrical current is passed down the wire making its tip heat up allowing discrete burns (ablation) to be placed inside the heart. The ablated heart muscle doesn't conduct electricity which stops the VT and prevents it recurring.\n\nSome patients are so frail that ablation cannot be performed safely. A recent clinical trial has shown that VT can be treated in such patients using radiotherapy, which is usually used to treat tumours with high energy radiation. This approach is non-invasive, painless and requires no sedation or anaesthesia.\n\nThis study will test whether VT can be successfully treated using stereotactic ablative radiotherapy. This can deliver high dose radiotherapy very precisely, whilst minimising the risk of damage to healthy tissues.",[28,111,112,113],"Ventricular Tachycardia","Structural Heart Abnormality","Heart Failure",[115,116,117],"radiotherapy","ventricular tachycardia","heart failure",{"date":91,"type":37},{"date":120,"type":37},"2023-01-12",{"date":122,"type":21},"2026-05-02",{"name":124,"class":44},"Barts & The London NHS Trust",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":45},"100594627","concomitant-radiotherapy-and-new-drugs-in-metastatic-breast-cancer-100594627","NCT07021911","Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer","COMBaRT","Inclusion Criteria:\n\n* Patients suffering from stage IV breast cancer\n* Ongoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)\n* Candidates for radiation treatment (both palliative and curative).\n\nExclusion Criteria:\n\n* Previous radiation treatment on the same site\n* Absolute contraindications to radiotherapy\n* Systemic treatment administered as part of a clinical trial",{"count":133,"type":21},300,"The primary objective of the study is to describe the tolerance profile of radiation treatments performed during systemic treatment with new drugs (molecular targeted therapies, immunotherapy, others).",[136,28],"Breast Cancer",[138,115,139,140],"breast cancer","stereotactic radiotherapy (SABR)","side effects","2025-06-11",{"date":143,"type":37},"2025-06-15",{"date":145,"type":37},"2023-05-17",{"date":147,"type":21},"2029-05-17",{"name":149,"class":44},"Fondazione Policlinico Universitario Campus Bio-Medico",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":45},"100454079","analysis-of-outcomes-and-adverse-events-of-patients-undergoing-radiation-therapy-100454079","NCT05192876","Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy","Analysis of Outcomes and Adverse Events of Patients Undergoing Radiation Therapy. Quality Control Using Data Base of Patient Records 2000-2025","Inclusion Criteria:\n\n* Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital\n\nExclusion Criteria:\n\n* No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital \\\u003C16 years,\\> 105 years","16 Years","105 Years",{"count":160,"type":21},25000,"Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025",[163,28,164],"Radiotherapy; Adverse Effect","Quality of Life","2025-05-17",{"date":167,"type":37},"2025-05-21",{"date":169,"type":37},"2000-01-01",{"date":171,"type":21},"2025-12-31",{"name":173,"class":44},"Daniel Zwahlen",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":182,"minAge":18,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":186,"conditions":187,"keywords":193,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100539617","advanced-radiotherapy-art-in-gynecological-cancer-patients-gyn-art-100539617","NCT06306170","Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)","Efficacy of Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)","GYN-ART","Inclusion Criteria:\n\n* gynecologic cancer patients\n* \\>18 years old\n* treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)\n\nExclusion Criteria:\n\n* other tumors\n* \\> 90 years old","FEMALE","90 Years",{"count":185,"type":21},1000,"This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.",[188,189,28,190,191,192],"Gynecologic Cancer","Radiotherapy Side Effect","Survivorship","Progression, Disease","Progression, Clinical",[188,194,195,196,197,198],"Image Guided Radiotherapy","PET\u002FCT","Intensity Modulated Radiotherapy","Stereotactic Body Radiotherapy","Oligometastases","2025-04-19",{"date":201,"type":37},"2025-04-22",{"date":203,"type":37},"2024-02-15",{"date":205,"type":21},"2029-02-15",{"name":207,"class":44},"IRCCS San Raffaele",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":215,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":226,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":45},"100461493","efficacy-of-the-vacucis-candida-autovaccine-100461493","NCT05289375","Efficacy of the Vacucis Candida® Autovaccine","Efficacy of the Vacucis Candida® Autovaccine in the Management of Chronic Oral Candidiasis. Randomized Triple-blind Randomized Clinical Trial.","Inclusion Criteria:\n\n* Patients with a history of RT in the head and neck region that directly or indirectly involves any of the jaws.\n* Adult patients\n* Hemodynamically stable patients without contraindications to receive an autovaccine (see exclusion)\n* Patients with a stable oncological situation without active tumor\n* Patients who present candidiasis demonstrated by clinical examination (signs and symptoms of candidiasis) and microbiological (culture).\n\nExclusion Criteria:\n\n* Minor patients\n* Pregnant patients\n* Patients with an unstable medical situation, both from a hemodynamic and oncological point of view (advanced tumors with metastases, recurrences or inoperable tumors)\n* Patients undergoing treatment with CT that involves an affectation of the immune system\n* Patient under treatment with antifungals for mycoses of any origin\n* Allergy to the active substance or to any of the other components of Vacucis.\n* Serious disorders of the immune system.\n* Diseases that severely affect immunity.\n* Presence of fever.\n* People with allergies to yeasts\n* People with allergy to chloramphenicol\n* Patients treated with MAOIs (monoamine oxidase inhibitors)",true,{"count":217,"type":21},46,[57],"Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works.\n\nObjective: To evaluate the reduction\u002Fsuppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo.\n\nMaterial and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy.\n\nA descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p \\\u003C 0.05 will be considered significant.",[221,222,28,223,224,225],"Oral Candidiasis","Oral Candidiasis Recurrent","Candida Albicans Infection","Microbial Colonization","Xerostomia",[227],"oral candidiasis","NOT_YET_RECRUITING","2024-10-15",{"date":231,"type":37},"2024-10-17",{"date":233,"type":21},"2025-04-30",{"date":235,"type":21},"2027-12-31",{"name":237,"class":44},"University of Santiago de Compostela",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":45},"100529950","short-term-outcomes-after-proton-and-photon-radiotherapy-for-idh-mutated-grade-2-and-3-gliomas-100529950","NCT06180434","Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas","SOPRANO","Inclusion Criteria:\n\n* Histopathologically confirmed WHO grade 2 or grade WHO 3 IDHmt glioma\n* Treatment with radiotherapy delivered between 1 of January 2018 and completed before or on the 30th of June 2022\n* Treatment with chemotherapy delivered after radiotherapy (PCV or Temozolomide)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Prior cranial radiotherapy\n* Contra-indication for MRI imaging\n* Chemotherapy delivered before radiotherapy\n* Dose and fractionation other that standard dose (50.4 Gy in 28 fractions for Grade 2 and 59.5 Gy in 33 fractions for Grade 3)\n* Combination photon and proton therapy\n* Patient has previously opted-out of the use of their data for research",{"count":246,"type":21},320,"Rationale:\n\nProton beam therapy has recently become available for the treatment of patients with WHO grade 2 and 3 IDH mutated (IDHmt) glioma in the Netherlands. The dose distributions associated with proton therapy have substantially reduced the volume of the normal brain irradiated with low and intermediate radiotherapy doses. Whether this impacts rates of progressive disease or safety issues and how this compares with a similar population treated with photon therapy is currently unknown.\n\nObjective:\n\nTo investigate short term outcomes after proton and photon radiotherapy for grade 2 and 3 IDHmt glioma.",[249,28],"Glioma",[251,252,253],"Neuro-oncology","Proton therapy","Photon therapy","2024-10-09",{"date":229,"type":37},{"date":257,"type":37},"2024-05-01",{"date":259,"type":21},"2025-11-01",{"name":261,"class":44},"Erasmus Medical Center",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":271,"conditions":272,"keywords":277,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":45},"100519392","microsurgical-resection-of-intramedullary-spinal-cord-metastases-100519392","NCT06042946","Microsurgical Resection of Intramedullary Spinal Cord Metastases","Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study","Inclusion Criteria:\n\n* Adult patients admitted to one of the participating centres and treated for ISCM\n* Available documentation of admission and postoperative status\n\nExclusion Criteria:\n\n\\- Patients under the age of 18",{"count":270,"type":21},60,"The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.\n\nThe hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.\n\nSecondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.\n\nThe investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.\n\nPrimary endpoint (analysed in surgically treated ISCM patients):\n\nFunctional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.\n\nThe McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.\n\nSecondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):\n\n* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function \u002F voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.\n* Ambulatory status and continence at 90 days, 6 \\& 12 months (determined by mJOA subscores)\n* Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)\n* Impairment Scale at 90 days, 6 and 12 months\n* Rate \\& type of complications at 90 days after treatment according to The Novel Therapy\n* Disability-Neurology Grade (TDN grade)16\n* Overall survival (in days)",[273,274,275,28,276],"Spinal Cord Metastasis","Spinal Cord Tumor Malignant Intramedullary","Functional Outcome","Spinal Cord Neoplasms",[278],"Spinal cord metastasis","2024-08-20",{"date":281,"type":37},"2024-08-21",{"date":283,"type":37},"2023-09-01",{"date":285,"type":21},"2025-07-31",{"name":287,"class":44},"Cantonal Hospital of St. Gallen",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":182,"minAge":18,"maxAge":53,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":45},"100531268","safety-assessment-of-concurrent-radiotherapy-and-novel-systemic-therapy-for-breast-cancer-100531268","NCT06197581","Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer","RADIOCOM","Inclusion Criteria:\n\nECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall\u002Fbreast with or without lymph node regions.\n\nNeed to receive one of the following therapies according to guidelines, capetabine, CDK4\u002F6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.\n\nExclusion Criteria:\n\nMale breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and\u002For after radiotherapy. With severe other disease.",{"count":296,"type":21},148,[57],"Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4\u002F6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy，despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall \u002F breast ± lymphatic drainage area and requiring capecitabine, CDK 4\u002F 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.",[300,28,301,302,303,304,305,306],"Breast Cancer, Familial Male","Chemotherapeutic Toxicity","Immune Checkpoint Inhibitor","CDK4\u002F6 Inhibitor","Trastuzumab","Pertuzumab","PARP Inhibitor",[136,308,309,310,304,305,311,312,313],"Radiotherapy","Adverse events","Capecitabine","Immune checkpoint inhibitor","CDK4\u002F6 inhibitor","PARP inhibitor","2024-08-19",{"date":281,"type":37},{"date":317,"type":37},"2024-01-12",{"date":319,"type":21},"2027-01-15",{"name":321,"class":44},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":45},"100548216","phase-1-neoadjuvant-radio-chemotherapy-safety-pilot-study-in-patients-with-glioblastoma-100548216","NCT06418113","Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma","GLINERA","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Unifocal disease.\n* Unilobar tumor.\n* Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection.\n\nExclusion Criteria:\n\n* Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease.\n* Midline shift greater than 1 cm.\n* Intracranial hypertension symptoms requiring corticosteroid treatment.\n* Synchronous neoplasia.\n* Any contraindication for surgery, radiotherapy, or TMZ treatment.\n* Cognitive impairment.\n* Rejection of informed consent.\n* Inability to follow up for 2 years.\n* Women of childbearing potential according to the Clinical Trial Facilitation Group (CTFG) criteria. (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01-About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1.pdf)\n* Hypersensitivity to the active ingredient or any excipients of the investigational drug.","75 Years",{"count":331,"type":21},12,[333],"PHASE1","The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are:\n\n* What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula?\n* What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life?\n\nParticipants will undergo the following tasks and treatments:\n\n* Stereotactic biopsy and diagnosis confirmation.\n* Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide.\n* Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring.\n* Maintenance temozolomide administration for 6 months.\n\nResearchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes.",[336,337,338,28,339],"Glioblastoma","Glioblastoma Multiforme","Glioblastoma, IDH-wildtype","Cancer Brain","2024-05-13",{"date":342,"type":37},"2024-05-16",{"date":344,"type":37},"2024-03-21",{"date":346,"type":21},"2027-03-21",{"name":348,"class":44},"Hospital San Carlos, Madrid",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":45},"100547226","recombinant-human-thyroid-stimulating-hormone-for-radioiodine-131i-treatment-100547226","NCT06405217","Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment","Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced\u002FMetastatic Differentiated Thyroid Cancer","Inclusion Criteria:\n\n* Age: 18\\~75 years old (including 18 and 75 years old);\n* ECOG: 0-2 points;\n* Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.\n* Hemoglobin ≥80g\u002FL, neutrophil ≥1.5×109\u002FL, platelet count ≥80×109\u002FL, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml\u002Fmin, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g\u002FL;\n* Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);\n* Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up.\n\nExclusion Criteria:\n\n* Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association classification); 3) Poorly controlled diabetes (fasting blood sugar \\>10mmol\u002FL); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU\u002FmL; hepatitis C: positive hepatitis C virus RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.\n* Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;\n* Unable to quit or with a history of psychiatric medication abuse;\n* Allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131I) or its excipients;\n* Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;\n* Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening;\n* Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;\n* Male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study;\n* Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.",{"count":357,"type":21},30,[57],"Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer .\n\nExperimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg\u002F1.0mL\u002Fpiece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks.\n\nThe two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\\>30mU\u002FL). The efficacy and adverse reactions were observed.",[361,362,28],"DTC - Differentiated Thyroid Cancer","Thyroid Stimulating; Hormone, C","2024-05-03",{"date":365,"type":37},"2024-05-08",{"date":367,"type":37},"2024-04-20",{"date":369,"type":21},"2026-12-31",{"name":371,"class":44},"Nanjing First Hospital, Nanjing Medical University",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":379,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":390,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":411},"100520029","phase-2-lithium-treatment-to-prevent-cognitive-impairment-after-brain-radiotherapy-100520029","NCT06051240","Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy","LiBRA","Inclusion Criteria:\n\n* Age \\>5 years.\n* Age \\\u003C18 years at time of radiotherapy.\n* Has received cranial\u002Fcraniospinal radiation treatment of brain tumor within the last 7 years.\n* Adequate contraceptive method to prevent pregnancy\\* during the entire lithium treatment period and six months thereafter.\n* Negative pregnancy test\\* at screening, at start of study treatment, and monthly thereafter.\n* Written informed consent from patient and\u002For caregiver.\n\nExclusion Criteria:\n\n* Allergy\u002Fhypersensitivity to lithium or any of the excipients\n* Renal failure (Cystatin C derived Glomerular Filtration Rate \\\u003C 60).\n* Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).\n* Uncontrolled hypothyroidism.\n* Pregnancy or breast feeding.\n* Severe fluid or electrolyte imbalance.\n* Karnofsky-Lansky score \\\u003C 60.\n* Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).\n* Inclusion in other study protocol precluding inclusion in this study.","5 Years",{"count":381,"type":21},84,[24],"Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol\u002Fl) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors.\n\nPrimary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.",[385,386,189,28,387,388,389],"Cognitive Impairment","Cognitive Decline","Brain Tumor","Memory Impairment","Late Effect of Radiation",[391,392,393,394,395,396,397,398,399,400],"lithium","neuroprotection","neuroprotective","regenerative","prevention","radiation","pediatric brain tumor","brain tumor","cognition","cognitive","2024-04-11",{"date":403,"type":37},"2024-04-12",{"date":405,"type":37},"2024-02-16",{"date":407,"type":21},"2033-08-31",{"name":409,"class":410},"Region Stockholm","OTHER_GOV",2,{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":425,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":45},"100540177","de-escalated-radiotherapy-for-primary-tumor-after-neoadjuvant-therapy-with-toripalimab-plus-chemotherapy-for-nasopharyngeal-carcinoma-100540177","NCT06313450","De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Pathologically confirmed nasopharyngeal carcinoma, patients who have not received anti-cancer therapy;\n2. ECOG performance status score (PS score) 0 or 1.\n3. 18-70 years old.\n4. Stage II-III except T2N0M0 (AJCC 8th).\n5. Neutrophil count ≥ 1.5 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL and platelet count ≥ 100 × 10\\^9\u002FL.\n6. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), bilirubin ≤ 1.5 times ULN; Creatinine clearance ≥ 60 ml\u002Fmin\n7. Patients are required to sign an informed consent form and must be willing and able to comply with the visits, treatment plan, laboratory tests, and other requirements specified in the study protocol\n\nExclusion Criteria:\n\nPatients will be excluded from the study, if any of the following criteria is met:\n\n1. Over the age of 70 or under the age of 18.\n2. HBsAg positive and HBV DNA ≥ 1 × 10\\^3 copies\u002Fml\n3. HCV antibody positive.\n4. Subjects with active, known or suspected autoimmune diseases were excluded from the study. Eligible participants included those with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions that do not require systemic therapy such as vitiligo, psoriasis, or alopecia.\n5. History of interstitial lung disease;\n6. Receiving systemic sex hormones or other immunosuppressive therapy at equivalent doses ≥ 10 mg prednisone\u002Fday within 28 days prior to signing informed consent; Subjects with systemic sex hormone doses ≤ 10 mg prednisone\u002Fday or inhaled\u002Ftopical corticosteroids were eligible.\n7. Received or about to receive live vaccines within 30 days before signing the informed consent form;\n8. Pregnant or lactating women;\n9. Other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer;\n10. Known previous hypersensitivity to macromolecular protein preparations, or to any component of Toripalimab;\n11. Human immunodeficiency virus (HIV) infection.\n12. Other conditions that may affect the safety of subjects or trial compliance as judged by the investigator, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors;",{"count":419,"type":21},112,[57],"In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy.",[423,28,424],"Nasopharyngeal Carcinoma","IMMUNOTHERAPY",[423,426,427],"de-escalated radiotherapy","immunotherapy","2024-03-15",{"date":430,"type":37},"2024-03-19",{"date":432,"type":37},"2024-03-04",{"date":434,"type":21},"2028-02-01",{"name":436,"class":44},"Sun Yat-sen University",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":453,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":411},"100431678","phase-2-adaptive-radiotherapy-for-oropharynx-cancer-100431678","NCT04901234","Adaptive RadioTherapy for OroPharynx Cancer","Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial","ART-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Stage T3-T4N0-3 as per AJCC 8th edition\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Planned for curative radiotherapy +\u002F- chemotherapy\n* For females of child-bearing age, a negative pregnancy test\n* Patients treated with induction chemotherapy can be included if they have residual tumor in place.\n\nExclusion Criteria:\n\n* Previous irradiation of the head and neck (HNC) region, excluding superficial radiation therapy for non-melanomatous skin cancer\n* Previous surgery of the HNC region (except for incisional or excisional biopsies)\n* Pregnancy or breastfeeding\n* Connective tissue disease\n* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.\n* Patients with contra-indications to MRI will be excluded.",{"count":446,"type":21},120,[24],"This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.",[450,28,189,451,452],"Oropharynx Cancer","Dysphagia","MRI",[454,308,455,456],"Oropharynx cancer","Adaptation","Magnetic resonance imaging","2023-12-11",{"date":459,"type":37},"2023-12-12",{"date":461,"type":37},"2021-07-30",{"date":463,"type":21},"2026-12",{"name":465,"class":44},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":215,"sex":182,"minAge":473,"maxAge":105,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":228,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":4},"100458711","phase-3-hypo-versus-conventional-fractionation-in-reconstructed-breast-cancer-mastectomy-patients-100458711","NCT05253170","Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients","A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy","Inclusion Criteria:\n\n* Female patient who underwent mastectomy for invasive breast cancer\n* Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander\n* (y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy\n* Eastern Cooperative Oncology Group Performance ≤ 2\n* Age ≥ 19 years\n* Patients who agreed to participate in the study\n\nExclusion Criteria:\n\n* Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery\n* Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy\n* Patients who are using or planning to use an air expander\n* Patients receiving radiation therapy for salvage or palliative purposes\n* Patients with distant metastases at the time of diagnosis\n* Patients who are scheduled to undergo concurrent chemoradiation therapy\n* Patients with bilateral breast cancer\n* Male breast cancer patients\n* Patients who have previously received radiation therapy for the ipsilateral breast or supraclavicular area\n* Patients with history of cancers other than thyroid cancer, intraepithelial cancer of the cervix, or skin cancer\n* Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or other benign tumors based on histological diagnosis","19 Years",{"count":475,"type":21},622,[477],"PHASE3","This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.",[136,28],[481,482,483,484,485,486],"Mastectomy","Reconstruction","Radiation therapy","Conventional fractionation","Hypofractionation","Complication","2022-02-23",{"date":489,"type":37},"2022-03-11",{"date":491,"type":21},"2022-04-01",{"date":493,"type":21},"2032-12-31",{"name":495,"class":44},"Seoul National University Bundang Hospital",{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":182,"minAge":18,"maxAge":329,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":45},"100443820","phase-3-medial-vs-entire-supraclavicular-lymph-node-radiation-therapy-for-patients-with-invasive-breast-cancer-100443820","NCT05059379","Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer","A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery","SUCLANODE","Inclusion Criteria:\n\n1. ECOG 0-1\n2. Newly diagnosed invasive breast cancer\n3. Initial clincial diagonosis stage is T1-4, N0-3a\u002Fb, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a\u002Fb, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a\u002FbM0.\n4. Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.\n5. Should receive ≥6 cycles standard neoadjuvant and\u002For adjuvant chemotherapy (taxane and\u002For anthracycline based).\n6. Enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy.\n7. For ER and\u002For PR positive patients, the duration of anticipated endocrine therapy should be≥5 year ; For HER2 postive patients, the duration of anticipated herceptin should be 1 year.\n8. Writtern, informed consent.\n\nExclusion Criteria:\n\n1. Initinal clinical diagnosis N3c (supraclavicualr node metastasis)\n2. T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy\n3. Distant metastasis\n4. Bilateral breast cancer or previously contralateral breast cancer\n5. Positve sentinal lymph node with no axillary dissection\n6. ECOG ≥2\n7. Could not tolerate chemotherapy and anti-HER2 target treatment\n8. Active infectious\n9. History of radiotherapy\n10. Serious medical complcation\n11. Breast cancer during pregnancy and lactation\n12. Had simultaneousl or previous secondary malignancies, except for skin basal cell carcinoma and cervical carcinoma in situ.\n13. Inaccessibility for follow-up\n\n    \\-",{"count":505,"type":21},1650,[477],"Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.",[136,28,509],"Effect of Radiation Therapy",[138,511,115],"supraclavicular lymph node","2021-10-17",{"date":514,"type":37},"2021-10-25",{"date":516,"type":37},"2021-09-20",{"date":518,"type":21},"2027-08",{"name":520,"class":44},"Fudan University"]