[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"germinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:germinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,76,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100639506","safety-and-efficacy-of-vertebral-body-sparing-craniospinal-irradiation-with-proton-therapy-in-pediatric-tumors-100639506",false,"NCT07589361","Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors","Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation (VBS-CSI) With Proton Therapy in Pediatric Tumors: A Single-Center Prospective Observational Cohort Study","VBS-CSI-PT-PED","Inclusion Criteria:\n\n* The patient's legal guardian voluntarily signs the written informed consent form.\n* Age at diagnosis \\> 3 years and ≤ 18 years.\n* Histopathologically confirmed diagnosis of a central nervous system (CNS) tumor.\n* Indication for craniospinal irradiation (CSI) confirmed by multidisciplinary team (MDT) discussion.\n* Karnofsky Performance Score (KPS) ≥ 80.\n* For postoperative patients, complete healing of the surgical incision with no evidence of wound infection or other complications.\n* For women of childbearing potential, effective contraception must be used for at least one month prior to screening, and they must commit to continued contraception throughout the study period and for the required time after study completion.\n\nExclusion Criteria:\n\n* Previous receipt of any form of spinal radiotherapy.\n* Previous major spinal surgery for any reason.\n* Presence of clinically significant and confirmed spinal deformity at enrollment (e.g., Cobb angle \\> 10° measured by MRI or X-ray).\n* Presence of medical contraindications to proton radiotherapy.\n* Presence of any severe, uncontrolled systemic disease (e.g., active infection, severe cardiac, hepatic, renal, or respiratory insufficiency) that, in the investigator's judgment, makes the subject unsuitable for treatment under this protocol.\n* Female patients who are pregnant or breastfeeding.\n* Presence of any severe cognitive or psychiatric disorder that prevents understanding of or cooperation with study assessments.","ALL","4 Years","18 Years",{"count":21,"type":22},38,"ESTIMATED","OBSERVATIONAL","his is a single-center, prospective observational study in children and adolescents with central nervous system tumors who need whole-brain and whole-spine radiation therapy (craniospinal irradiation, CSI). The study uses proton therapy with a special vertebral body-sparing (VBS) technique to protect the front and center of the vertebrae, which helps preserve bone marrow function and growth. The main goals are to find safe dose limits for the vertebrae and check how often severe side effects occur. The study will also look at bone marrow preservation, spinal deformity, tumor control, survival, chemotherapy completion, neurocognitive function, quality of life, and growth and development for up to 5 years after treatment.",[26,27,28,29,30],"Pediatric Central Nervous System Tumors","Medulloblastoma","Germinoma","Ependymoma","Atypical Teratoid\u002FRhabdoid Tumor (AT\u002FRT)","NOT_YET_RECRUITING","2026-05-10",{"date":34,"type":35},"2026-05-15","ACTUAL",{"date":37,"type":22},"2026-04-30",{"date":39,"type":22},"2033-12-31",{"name":41,"class":42},"Ruijin Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100544433","phase-2-a-study-of-lower-radiotherapy-dose-to-treat-children-with-cns-germinoma-100544433","NCT06368817","A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma","A Phase II Trial Evaluating Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas","Inclusion Criteria:\n\n* Patients must be ≥ 3 years and \\\u003C 30 years at the time of study enrollment\n* Patients must be newly-diagnosed primary localized germinoma of the suprasellar and\u002For pineal region by pathology and\u002For serum and\u002For CSF hCGbeta 5-50 mIU\u002FmL AND institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required\n* Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU\u002FmL in serum and\u002For CSF AND institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists) in both serum and CSF. No histologic confirmation required\n* Patients with hCGbeta 51-100 mIU\u002FmL in serum and\u002For CSF and institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required\n* Patients with germinoma of the basal ganglia and or\u002Fthalamic primary sites are eligible\n* Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible\n* Patients with germinoma admixed with mature teratoma are eligible\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS\n* Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that must be obtained within 31 days prior to enrollment.)\n* Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis\u002Fprior to enrollment. If surgical resection is performed, patients must have pre-operative and post-operative brain MRI with and without gadolinium. The post-operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required\n* Patients must have a spine MRI with gadolinium obtained at diagnosis\u002Fprior to enrollment\n* Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later\n* Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS\n* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery. Of note, lumbar CSF should not be performed prior to obtaining spine MRI, as this can make interpretation of the spine MRI less clear\n* Patients must have CSF tumor markers obtained prior to study enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy\u002Fsurgery are combined, CSF tumor markers should be collected first. Ideally serum and CSF tumor markers should be collected at the same time and processed without delay\n* For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For patients with solid tumors: Platelet count \\>= 100,000\u002FuL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For patients with solid tumors: Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For pediatric patients (age 3-17 years): A serum creatinine based on age\u002Fsex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: 3 to \\\u003C 6 years; maximum serum creatinine (mg\u002FdL): 0.8 (male); 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; maximum serum creatinine (mg\u002FdL): 1 (male); 1 (female)\n  * Age: 10 to \\\u003C 13 years; maximum serum creatinine (mg\u002FdL): 1.2 (male); 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; maximum serum creatinine (mg\u002FdL): 1.5 (male); 1.4 (female)\n  * Age: ≥ 17 years; maximum serum creatinine (mg\u002FdL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).\n  * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility.\n  * For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n    * Creatinine clearance ≥ 70 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \\[ALT\\]) ≤ 135 U\u002FL (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\n* CNS toxicity =\\\u003C grade 2\n* Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study\n\nExclusion Criteria:\n\n* Patients with any of the following malignant pathological elements are not eligible:\n\n  * Endodermal sinus (yolk sac)\n  * Embryonal carcinoma, choriocarcinoma\n  * Malignant\u002Fimmature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)\n* Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible\n* Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n\n  * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","3 Years","29 Years",{"count":53,"type":22},240,"INTERVENTIONAL",[56],"PHASE2","This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \\& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.",[59,60,28,61,62,63],"Basal Ganglia Germinoma","Diabetes Insipidus","Pineal Region Germinoma","Suprasellar Germinoma","Thalamic Germinoma","RECRUITING","2026-04-28",{"date":67,"type":35},"2026-05-04",{"date":69,"type":35},"2024-10-22",{"date":71,"type":22},"2033-11-04",{"name":73,"class":74},"Children's Oncology Group","NETWORK",109,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100482591","molecular-epidemiology-of-pediatric-germ-cell-tumors-100482591","NCT05564026","Molecular Epidemiology of Pediatric Germ Cell Tumors","Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics","Inclusion Criteria:\n\n* Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.\n* The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.\n* Patients must be diagnosed at \\\u003C 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.\n* Participants must be able to complete study related documents in English or Spanish.\n* All patients and\u002For their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.\n* All institutional, FDA, and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish",{"count":84,"type":22},1151,"A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.",[87,28,88,89,90,91,92,93,94],"Germ Cell Tumor","Teratoma","Embryonal Carcinoma","Yolk Sac Tumor","Choriocarcinoma","Mixed Germ Cell Tumor","Late Effects","Pediatric Germ Cell Tumor","2025-10-23",{"date":97,"type":35},"2025-10-24",{"date":99,"type":35},"2023-04-12",{"date":101,"type":22},"2027-06-30",{"name":73,"class":74},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":112,"studyType":23,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100412277","proton-therapy-research-infrastructure--protrait--neuro-oncology-100412277","NCT04648462","Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology","Inclusion Criteria:\n\n1. All brain tumors with a favorable prognosis (median survival \\> 10 year)\n2. Age ≥ 18 years\n3. ECOG performance status 0 - 1 \u002F Karnofsky performance status 80 - 100\n4. No - minimal neurocognitive impairment\n5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi)\n6. Informed consent\n\nExclusion Criteria:\n\n1. Not eligible for chemotherapy\n2. Eligible for stereotactic radiotherapy",{"count":111,"type":22},1500,"5 Years","The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.",[115,29,116,117,118,119,120,121,122,123,28,124],"Astrocytoma","Ganglioglioma","Oligodendroglioma","Optic Nerve Glioma","Meningioma","Nerve Sheath Neoplasms","Adenoma","Craniopharyngioma","Hemangiopericytoma","Neurilemmoma","2024-11-25",{"date":127,"type":35},"2024-11-26",{"date":129,"type":35},"2018-01-01",{"date":131,"type":22},"2035-01-01",{"name":133,"class":42},"Maastricht Radiation Oncology",3]