[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chordoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chordoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,54,66,111,136,162,190,217,242,268,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100054169","clinical-genetics-branch-eligibility-screening-survey-100054169",false,"NCT07005297","Clinical Genetics Branch Eligibility Screening Survey","Clinical Genetics Branch (CGB) Eligibility Screening Survey","* INCLUSION CRITERIA\n\nThere is no age restriction; therefore, viable neonates may be included. This eligibility screening protocol is intended for individuals meeting one or more of the following criteria:\n\n1. Personal or family history of a diagnosis of a syndrome being actively investigated in one of the following CGB study protocol:\n\n   * Protocol 000678: Medical history of neoplasia of an unusual type, pattern, or number.\n   * Protocol 11C0255: A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any age, regardless of family history, or family or personal medical history of neoplasia consistent with the diagnosis of LFS or LFL.\n   * Protocol 20C0107: Individuals with a clinical diagnosis of a RASopathy, including Costello syndrome, Noonan syndrome, Noonan syndrome with multiple lentigines, Cardiofaciocutaneous syndrome, Legius syndrome, capillary arteriovenous malformation syndrome, or others, are eligible. Published clinical diagnostic criteria exist for most of the clinical RASopathy syndromes and differ by syndrome. It will be uncommon for individuals to have a clinical diagnosis and not have had molecular genetic testing. All individuals considered by the study team to be at risk for a RASopathy who have not had prior genetic testing will have this completed as part of the study. The rare individuals with a clinical diagnosis of a RASopathy who are not found to carry a corresponding pathogenic or likely pathogenic variant in a known RASopathy gene will be considered for exome analysis for identification of potentially novel RASopathy germline variation.\n   * Protocol 11C0034: An individual with histologically-confirmed PPB and\u002For other DICER1-related tumors\n   * Protocol 02C0052: The participants will be affected by an IBMFS, or be members of a family with an IBMFS, and be at risk of being affected or carriers of the syndrome. Except for the rare X-linked recessive disorder (e.g. some dyskeratosis congenita patients), there should be equal numbers of male and female probands and family members. These IBMFS have been reported in most racial and ethnic groups, and thus all such groups will be included. The age range will be from birth to old age (grandparents of probands). The majority of the probands will be children (10-20% will be adults), and their parents and grandparents will be adults. All racial\u002Fethnic groups are eligible.\n   * Protocol 02C0211: Personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age.\n   * Protocol 78C0039: Family or personal medical history of neoplasia of an unusual type, pattern, or number\n2. Personal or family history of medical condition, malignancy, and\u002For benign neoplasm suggestive of hereditary cancer predisposition being actively investigated in the following CGB study protocol:\n\n   * Protocol 000678: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.)\n   * Protocol 11C0255: An individual with a sarcoma diagnosed under the age of 45; AND - At least one first-degree relative (parents, brothers, sisters and children) with a cancer of any kind diagnosed under the age of 45; AND - A third family member who is either a first- or second-degree relative (such as grandparents, aunts, uncles, nieces, nephews, and grandchildren) with cancer diagnosed under the age of 45 or having a sarcoma at any age.\n   * Protocol 001109: On referral, persons \\>= 12 years with Fanconi Anemia (FA) primarily from North America will be included. An individual with FA who is 8 -11 years can also be included if they have a history of persistent oral potentially malignant lesion (OPMLs), dysphagia, or other concerning symptoms. Individuals with prior cancer diagnosis are eligible.\n   * Protocol 11C0034: An individual from the general population with one or more of the unique tumors of the types associated with DICER1 including (but not exclusively), PPB, cystic nephroma, ovarian Sertoli-Leydig cell and other sex cordstromal tumors, ocular medulloepithelioma, nasal chondromesenchymal hamartoma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, pituitary blastoma, ovarian sarcoma, CNS sarcoma and\u002For thyroid cancer - regardless of their family history. Additional DICER1-related neoplasms may be identified in the future, and they will be added to the protocol as needed\n   * Protocol 02C0052: Fanconi anemia: FA patients have relatively specific birth defects, aplastic anemia, increased chromosome breakage in cells cultured with a DNA crosslinking agent such as mitomycin C (MMC) or diepoxybutane (DEB), pathogenic variant(s) in one of the cloned genes (six genes at this time), or assignment to one of the 7 or more complementation groups. Bone marrow failure is NOT required for the diagnosis, and approximately 25% do not have birth defects. FA has been diagnosed from birth to \\>50 years of age. FA Proven = positive chromosome breakage result, and\u002For pathogenic variant(s) in a known FANC gene. Patients in whom FA is suspected but whose chromosome breakage test is negative will still be considered if they have sufficient findings that lead the Principal Investigator to think they may be somatic mosaics and warrant further evaluation. Diamond Blackfan anemia: DBA patients have pure red cell aplasia with reticulocytopenia. Approximately 30% have physical abnormalities, often involving malformations of the thumbs. Approximately 90% are diagnosed within the first year of life. A pathogenic variant in a known DBA gene (RPS19 is currently the only known gene) is diagnostic, but lack of a pathogenic variant does not rule out DBA, since the cloned gene is responsible for only approximately 25% of the disease. Since many cases are sporadic or occur in families with silent carriers, patients without a positive family history will be included. Currently DBA is diagnosed by clinical findings after exclusion of known causes of red cell aplasia. Approximately 90% have elevated red cell adenosine deaminase levels, a finding which is supportive, but not diagnostic, of DBA. Dyskeratosis congenita: DC patients develop dyskeratotic nails, lacy hyperpigmentation of the skin and mucous membrane leukoplakia as they age (the diagnostic clinical triad; two of the three are required for a firm diagnosis). Findings in young patients may be very subtle, and diagnoses are usually made in teenagers or young adults. More than 75% are male. DC patients are often diagnosed without hematologic abnormalities by dermatologists; however, some patients present with aplastic anemia prior to the evolution of the syndrome-related physical features. A pathogenic variant in the DKC1 gene is diagnostic, but normal DKC1 does not exclude DC. The diagnosis is often clinical, after exclusion of FA and other IBMFS. Shwachman Diamond Syndrome: SDS patients have neutropenia, malabsorption and failure to thrive due to exocrine pancreatic insufficiency. The gene has not yet been cloned. Pancreatic insufficiency is documented by direct measurement of pancreatic enzymes, low serum immunoreactive trypsinogen, or elevated fecal fat levels. Neutropenia requires an absolute neutrophil count of \\\u003C1500\u002Fmm3 on multiple occasions. Other causes of malabsorption such as cystic fibrosis, Pearson syndrome, and Johansson-Blizzard syndrome must be excluded. Cystic fibrosis will be excluded in patients who have a positive sweat test performed at an approved CF center. Amegakaryocytic thrombocytopenia: These patients have early onset thrombocytopenia (\\\u003C150,000\u002Fmm3), usually within the first year of life, due to absent, diminished, or abnormal bone marrow megakaryocytes, without antiplatelet antibodies. Physical examination is often normal; in particular, there are no abnormalities of the radial rays. Pathogenic variant(s) in the MPL gene are diagnostic, but normal MPL does not exclude this diagnosis. Thrombocytopenia absent radii: TAR patients have absent radii, usually bilateral, with intact thumbs (in contrast with FA and trisomy 18, where thumbs are absent if radii are absent), and thrombocytopenia at birth. Other radial aplasia syndromes such as Holt-Oram syndrome or VATER syndrome must be excluded. Severe Congenital Neutropenia: Patients with SCN have persistent and noncyclic low absolute neutrophil counts, with more than 2 measurements \\\u003C200\u002Fmm3, and a history of pyogenic infections during the first year of life, and bone marrow maturation arrest at the promyelocyte\u002Fmyelocyte stage. They do not have birth defects, and they usually have normal hemoglobin and platelet counts. They are designated Kostmann Syndrome (KS) only if there is a pattern of autosomal recessive inheritance. Pathogenic variant(s) in the neutrophil elastase gene (ELA2) are supportive of the diagnosis of SCN, but do not distinguish SCN patients from those with cyclic neutropenia, which is milder and not preleukemic. Many of the cases of SCN have been shown to be due to dominant pathogenic variant(s)s in ELA2. Pearson Syndrome: Pearson syndrome consists of malabsorption, neutropenia, alone or with anemia and\u002For thrombocytopenia, and metabolic acidosis. Onset is in infancy or early childhood. The diagnosis is strongly suspected if bone marrow examination reveals vacuoles in myeloid and erythroid progenitors, and ring sideroblasts. Confirmation derives from detection of deletions in mitochondrial DNA, which range from 2 to 8 kb in size, and include the respiratory enzymes. Absence of reports to date of cancer or leukemia in this syndrome may derive from early death due to the metabolic problems. Other bone marrow failure syndromes: There are occasional patients with a pattern of hematologic abnormalities, physical findings, malignancies, or family histories which are not characteristic of the syndromes described above, but which nonetheless suggests that they have a genetic bone marrow failure syndrome. There may be similar cases in the literature, or in the experience of the investigator, which may ultimately lead to assignment of these patients to a known or new syndrome. There are additional bone marrow failure syndromes which are even more rare, such as Revesz, WT, IVIC, radio-ulnar synostosis, ataxia-pancytopenia, etc. Syndromic classification of extremely rare disorders is facilitated if they are collected in one center. Since malignancy is often part of these syndromes, they will be eligible for enrollment in this protocol.\n   * Protocol 02C0211: Known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n   * Protocol 10CN188: Diagnose with chordoma or related tumor at any age and any primary site.\n   * Protocol 78C0039: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.). Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are required. The types of familial tumors that we are currently actively accruing include Familial Cancers: bladder, brain, chordoma, lung, nevoid basal cell carcinoma syndrome (NBCC) Familial Benign Neoplasms: meningiomas, neurofibromatosis 2 (bilateral acoustic neurofibromatosis) The types of familial tumors under active accrual and study are predominantly investigator- and hypothesis-driven. This approach permits CGB investigators to remain alert to the opportunities afforded by clusters of rare tumors in families and individuals, and to be more responsive to the dynamic research priorities in cancer genetics.\n3. Personal or family history of a genetic variant in a hereditary cancer predisposition being actively investigated in the following CGB study protocols:\n\n   * Protocol 11C0255: A personal history of a germline TP53 mutation; or, - A first or second- degree relative of a TP53 mutation carrier, regardless of mutation status\n   * Protocol 20C0107: Individuals with a germline variant (P\u002FLP or a variant of uncertain significance but predicted bioinformatically to be damaging) in a RASopathy-associated gene are eligible. These include but are not limited to: BRAF, CBL, HRAS, KRAS, LZTR1, MAP2K1, MAP2K2, MAP3K8, MRAS, NRAS, PPP1CB, PTPN11, RAF1, RASA1, RASA2, RIT1, RRAS, SHOC2, SOS1, SPRED1. From herein, we refer to 1) individuals with germline pathogenic variation in a RAS pathway gene AND 2) individuals with a clinical RASopathy diagnosis but in whom a genetic variant has not yet been identified as \"carriers.\" The first member of a family to be identified is termed a \"proband.\"\n   * Protocol 11C0034: An individual with a known or suspected DICER1 disease associated variant.\n   * Protocol 02C0052: An individual with a pathogenic variant(s) in a known FANC gene. Individual with Diamond Blackfan Anemia with a pathogenic variant in a known DBA gene (RPS19). Individuals with Dyskeratosis congenita with a pathogenic variant in the DKC1 gene. Individuals with Amegakaryocytic thrombocytopenia with pathogenic variants) in the MPL gene. Individuals with Severe Congenital Neutropenia with a pathogenic variant(s) in the neutrophil elastase gene (ELA2).\n\nEXCLUSION CRITERIA\n\nWhile this protocol is intended to be used by those meeting the inclusion criteria above, there are no explicit exclusion criteria for this study, since the initiative to complete the eligibility screener survey is at the will of the participant or his or her parent\u002Fguardian\u002FLAR.","ALL","1 Year","99 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Background:\n\nClinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 6 open clinical genetics studies at the CGB eligible for this screening process.\n\n* 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study (Cancer in Bone Marrow Failure)\n* 11C0255: Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome (Li Fraumeni Syndrome Study)\n* 11C0034: DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study (Pleuropulmonary Blastoma)\n* 02C0211: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma (Melanoma-Prone Families)\n* 10CN188: Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-susceptibility Genes (Sporadic Chordoma Study)\n\nThe following studies have their own study-specific screeners. If you are interested in these studies, please click the links below to fill out the relevant study screener:\n\n* 001109: Defining the Natural History of Squamous Cell Carcinoma in Fanconi anemia (SCC Screening in FA): https:\u002F\u002Fservice.cancer.gov\u002Ffanconi\n* 20C0107: Clinical, Genetic, and Epidemiologic Study of Children and Adults with RASopathies (RASopathies Study): https:\u002F\u002Fservice.cancer.gov\u002Fmyras\n\nObjective:\n\nTo find people to participate in active CGB cancer research studies.\n\nEligibility:\n\nPeople of any age who meet the eligibility criteria for one of the open CGB cancer research studies. You can learn more about the CGB cancer research studies by clicking on the links to the study-specific websites above. This typically involves a personal or family history of certain cancers that are being studied by researchers at CGB.\n\nDesign:\n\nParticipants will fill out a screening questionnaire to determine if they are eligible to participate in one or more CGB clinical genetics studies. The survey asks about personal health history, including cancer; family history; and genetic testing results and takes 15 to 20 minutes.\n\nEach study has its own eligibility criteria. Survey respondents will select which study (or studies) that are interested in participating in, and the relevant study team(s) will review the screener to determine eligibility to participate in the study. Participants who are determined to be eligible for a study based on their screener will be contacted by the respective study team to learn more about the study and to consent to enroll in the study if they choose to do so. Participants who consent to enroll in a study may be asked to provide medical records; samples such as blood, saliva, or other tissues; and to participate in activities such as phone interviews or surveys. They may be invited for evaluations at the clinical center. Every study activity is voluntary. None of the studies provide treatments. Participants may be contacted to consider enrolling in future studies.",[25,26,27,28,29,30,31,32,33,34],"Melanoma","Li-Fraumeni Syndrome","Pulmonary Blastoma","Chordoma","Congenital Bone Marrow Failure Syndromes","Costello Syndrome","Fanconi Anemia","CFC Syndrome (CFCS)","Legius Syndrome","RASopathies",[31,26,36,37,28,38,34,39,40],"Clinical Genetics Branch, NCI","Hereditary Melanoma","DICER-1 syndrome","Cancer","Inherited Bone Marrow Failure Syndromes","NOT_YET_RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":21},"2026-07-16",{"date":49,"type":21},"2036-01-01",{"name":51,"class":52},"National Cancer Institute (NCI)","NIH",1,{"id":55,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":57,"keywords":58,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":53},"100593350",{"count":20,"type":21},[25,26,27,28,29,30,31,32,33,34],[31,26,36,37,28,38,34,39,40],"2026-07-01",{"date":61,"type":45},"2026-07-02",{"date":63,"type":21},"2026-07-07",{"date":49,"type":21},{"name":51,"class":52},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":53},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","25 Years",{"count":76,"type":21},27,"INTERVENTIONAL",[79,80],"PHASE1","PHASE2","Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[83,84,85,86,87,88,89,28,90,91,92,93,94,95],"Neuroblastoma","Rhabdomyosarcoma","Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[97,98,99],"pediatric solid tumors","stem cell transplantation","graft manipulation","RECRUITING","2026-06-25",{"date":103,"type":45},"2026-06-30",{"date":105,"type":45},"2026-02-11",{"date":107,"type":21},"2030-02",{"name":109,"class":110},"University of Florida","OTHER",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":53},"100355629","children-and-adults-with-chordoma-100355629","NCT03910465","Children and Adults With Chordoma","Natural History Study of Children and Adults With Chordoma","* INCLUSION CRITERIA:\n* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written consent document.\n* Subjects with radiographically or histologically documented chordoma\n* Age greater than or equal to 2 years old\n* Subjects must be enrolled into NCI protocol 19-C-0016: Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors .\n\nEXCLUSION CRITERIA:\n\n-None","2 Years",{"count":120,"type":21},300,"Background:\n\nChordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease.\n\nObjective:\n\nTo learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments.\n\nEligibility:\n\nPeople ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016\n\nDesign:\n\nParticipants will be screened with their medical history.\n\nParticipants will have a visit to examine their disease. This will include:\n\n* Physical exam\n* Neurologic exam\n* CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body.\n\nParticipants will have other tests every 6-12 months:\n\n* Smell test\n* Surveys to assess their emotional, physical, and behavioral well-being and needs\n* Cognitive function tests\n\nParticipants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations.\n\nSome participants may be asked to come to the clinic for more visits.\n\n...",[28],[124,125,126,127],"Rare Tumor","Comprehensive Evaluation and Recommendations","Collecting Clinical, Epidemiologic and Biological Data","Natural History","2026-06-17",{"date":130,"type":45},"2026-06-18",{"date":132,"type":45},"2019-04-16",{"date":134,"type":21},"2029-12-31",{"name":51,"class":52},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100441816","comparing-carbon-ion-therapy-surgery-and-proton-therapy-for-management-of-pelvic-sarcomas-involving-the-bone-100441816","NCT05033288","Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone","Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue\u002FBone) Involving the Bone","Inclusion Criteria:\n\n* Males and females \\>= 15 years of age\n* Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement\n* No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Patients capable of childbearing must agree to use adequate contraception\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Ability to provide written informed consent\n* Chemotherapy per institutional guidelines is allowed\n\nExclusion Criteria:\n\n* Patients receiving palliative treatment\n* Recurrent disease\n* Males and females \\\u003C 15 years of age\n* Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues\n* Patients with distant sarcoma metastases\n* Benign pelvic bone histologies\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception","15 Years",{"count":145,"type":21},72,"This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon\u002Fproton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.",[148,149,28,150,151],"Bone Sarcoma","Chondrosarcoma","Ewing Sarcoma of Bone","Pelvic Rhabdomyosarcoma","2026-03-11",{"date":154,"type":45},"2026-03-13",{"date":156,"type":45},"2022-01-20",{"date":158,"type":21},"2031-08-30",{"name":160,"class":110},"Mayo Clinic",3,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":169,"enrollmentInfo":4,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":179,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":188,"locationsCount":53},"100369511","blessed-expanded-access-for-dng64-car-v-for-advanced-pancreatic-cancer-sarcoma-and-carcinoma-of-breast-100369511","NCT04091295","BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast","Inclusion Criteria:\n\n* Patient is ≥12 years of age, either male or female for patients with sarcoma; \\>18 years of age, either male or female.with pancreatic cancer or carcinoma of breast.\n* Patient has pancreatic cancer or sarcoma or carcinoma of breast confirmed by pathologic examination at diagnosis.\n* Patients with advanced metastatic pancreatic cancer who have received systemic therapies such as FOLFIRINOX and gemcitabine + albumin-bound paclitaxel; patients with metastatic sarcoma who have disease progression after two or more lines of systemic treatments and not amenable to surgical resection or radiotherapy; specifically for osteosarcoma: have disease progression after high dose methotrexate, cisplatinum, doxorubicin and ifosfamide; for soft tissue sarcoma: have disease progression after doxorubicin + ifosfamide\u002Fmesna, gemcitabine, docetaxel, dacarbazine, trabectedin, pazopanib, eribulin; patients with metastatic carcinoma of breast who have disease progression with standard therapy (ACT), targeted therapies including aromatase inhibitors, trastuzumab, pertuzumab, enhertu, tyrosine kinase inhibitors, immune checkpoint inhibitors; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.\n* Patient is able to understand or is willing to sign a written informed consent.\n* Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion\n\nExclusion Criteria:\n\n* Patient is unwilling to provide formal informed consent.\n* Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion","12 Years","100 Years","EXPANDED_ACCESS","Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64-CAR-V intravenously or intratumorally at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 Vector Copies (VC) per dose one to three times a week. DNG64-CAR-V may be given alone or with one or more FDA approved cancer therapies\u002Fimmunotherapies, or with certain FDA authorized investigational agents.\n\nBased on previous Phase 1\u002F2 US based clinical studies, DNG64-CAR-V does not suppress the bone marrow or cause organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI (pseudoprogression). Further, tumor stabilization\u002Fregression\u002Fremission have occurred later during the treatment period with DNG64-CAR-V monotherapy. Therefore, DNG64 -CAR-V will be continued if the patient has clinical benefit and does not have symptomatic disease progression.",[173,93,174,149,175,28,176,177,178],"Pancreatic Cancer","MPNST (Malignant Peripheral Nerve Sheath Tumor)","Soft Tissue Sarcoma","Sarcoma","Carcinoma of Breast","Single Patient IND for Glioblastoma, Ovarian Carcinoma, Non-small Cell Lung Cancer , Prostate Cancer",[180,181,182,183],"tumor targeted gene therapy","human cyclin G1 inhibitor","cell cycle control","CCNG1 inhibitor","AVAILABLE","2026-03-02",{"date":187,"type":45},"2026-03-04",{"name":189,"class":110},"Aveni Foundation",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":77,"phases":200,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":53},"100505427","hypofractionated-protontherapy-in-chordomas-and-chondrosarcomas-of-the-skull-base-100505427","NCT05861245","Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base","Phase II Clinical Trial of Low-intervention Using Hypofractionated Protontherapy in Chordomas and Chondrosarcomas of the Skull Base","Inclusion Criteria for 5 fractions:\n\n* With a baseline classification on the Karnofsky performance status scale ≥ 70%.\n* With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base.\n* Who have signed the specific informed consent of the protocol, agreeing to participate in it.\n* Completion of magnetic resonance imaging with vascular assessment ruling out pre-existing vascular pathology (stenosis or atherosclerosis), including 3D T1 black-blood sequences, pre-contrast 3D TOF, 3D T2 with fat suppression, and perfusion sequences.\n* With a maximum tumor size of 50 cc.\n* Whose relationship to organs at risk (OARs) allows compliance with the necessary dose restrictions to receive hypofractionated proton therapy in 5 fractions.\n* Patients included in the study must meet dosimetric parameters that include:\n* Tumor CTV coverage of at least D95\\>90%.\n* Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem and spinal cord) according to the guidelines published and available in the literature:\n\nDose contnstraints for 5 fractions:\n\nOptic Nerves: D0.03cc ≤ 25 GyRBE, V23.5 \\\u003C 0.5cc. Chiasm:D0.03cc ≤ 25 GyRBE, V23.5 \\\u003C 0.5cc. Brainstem:D0.03cc ≤ 31 GyRBE,V23 \\\u003C 0.5cc. Spinal Chord: D0.03cc ≤ 30 GyRBE, V23 \\\u003C 035cc. Right and left temporal lobes: D0.03 cc ≤ 35 GyRBE, V30 ≤ 5.5 cc.\n\nInclusion Criteria for 25 fractions:\n\n* With a baseline classification on the Karnofsky performance status scale ≥ 70%.\n* With confirmed histological diagnosis of chordoma or chondrosarcoma of the skull base.\n* Who have signed the specific informed consent of the protocol, agreeing to participate in it.\n* Not considered candidates for the 5-fraction protocol due to tumor size exceeding 50 cc and\u002For the presence of vascular pathology (stenosis or atherosclerosis) identified on MRI with vascular sequences.\n* Tumor relationship to organs at risk allows compliance with the dose constraints required to receive hypofractionated proton therapy delivered in 27 fractions.\n* Patients included in the study must meet dosimetric parameters that include:\n* Tumor CTV coverage of at least D95\\>90%.\n* Correct compliance with the dose restrictions, at least in the nominal scenario, for critical organs (optic pathway, brain stem and spinal cord) according to the guidelines published and available in the literature:\n\nDose constraints for 25 fractions:\n\nOptic nerves: D0.03 cc ≤ 54.7 GyRBE. Optic chiasm: D0.03 cc ≤ 54.7 GyRBE. Brainstem: Surface: D0.03 cc ≤ 57.9 GyRBE. Core: D0.03 cc ≤ 54 GyRBE. Spinal cord: D0.03 cc ≤ 54 GyRBE. Right and left temporal lobes: V65 \\\u003C 1.7 cc, V60 ≤ 5.5 cc.\n\nTreatment planning with a minimum of 5 beams. In general, the use of a class solution with 6 beams will be proposed, including 2 lateral beams with gantry angles between 20° and 80°, depending on tumor location; 2 posterior oblique beams; and 2 anterior oblique beams. The latter four beams may include a couch rotation of at least 20° relative to the two lateral beams, with a minimum angular separation of at least 30° between ipsilateral oblique beams. Depending on individual patient characteristics, this class solution will be adapted to adjust specific gantry and couch angles for each field.\n\nIf this solution is not feasible due to patient-specific characteristics (surgical constraints, tumor location or laterality, etc.), a 5-beam solution will be evaluated, including 2 posterior oblique beams and 2 anterior oblique beams, in addition to a coronal field with the couch at 270° and a gantry angle between 40° and 90° depending on tumor location, or other configurations that increase the number of ipsilateral oblique beams with a minimum inter-beam separation of at least 30°.\n\nEvaluation of Linear Energy Transfer (LET) and biological dose:\n\nFor each treatment plan, the LET distribution obtained from the treatment planning system (TPS) will be evaluated, with particular attention to regions where LET values exceed 5 keV\u002Fμm, aiming to minimize such values. Equivalent biological dose distributions based on recognized models in the literature may also be assessed to support decision-making regarding the suitability of a given treatment plan\n\nExclusion Criteria:\n\n* Patients with distant metastases.\n* Patients who have received previous irradiation in the same location.\n* Patients whose clinical or dosimetric characteristics do not meet the inclusion criteria.\n* Patients who are simultaneously participating in another study that may affect the results of this protocol.","18 Years",{"count":199,"type":21},20,[201],"NA","The project is planned as a phase II clinical trial with a low level of intervention, for the prospective evaluation of the clinical results of radical or adjuvant treatment by proton therapy in chordomas and chondrosarcomas of the skull base using hypofractionation schemes in 5 fractions, with the aim of consolidating the scientific evidence that exists with high-precision techniques with photons, increasing this evidence by adapting this treatment scheme to the proton technique.\n\nIn addition, a cross-sectional prospective evaluation of the quality parameters of the dosimetry of hypofractionated proton therapy and an evaluation of the quality of life of these patients will be carried out.\n\n* Primary Objective\n\n  1. \\- Toxicity according to CTCAE-v5 criteria\n  2. \\- Local control determined by Magnetic Resonance with Gadolinium.\n* Secondary Objectives\n\n  1. To evaluate the quality of life of the patients, 3 months after the end of the treatment, using a specific questionnaire.\n  2. To evaluate the dosimetric benefits using techniques that allow an improvement in the dose gradient, improving the coverage of the CTV (Clinical Tumor Volume) and decreasing the dose in surrounding risk organs.",[28,149],[205,206,207,28,149],"Skull base","Protontherapy","Hypofractionation","2026-01-21",{"date":210,"type":45},"2026-01-23",{"date":212,"type":45},"2023-05-24",{"date":214,"type":21},"2033-05-24",{"name":216,"class":110},"Quironsalud",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":77,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":241},"100284739","sacral-chordoma-surgery-versus-definitive-radiation-therapy-in-primary-localized-disease-100284739","NCT02986516","Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease","Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)","SACRO","Inclusion Criteria:\n\n* Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.\n* Age≥18years\n* ECOG-performance status (PS) 0-2\n* No previous antineoplastic therapy\n* Macroscopic tumor detectable at MRI\u002FCT scan\n* Patient amenable for surgery\n* Patient amenable for RT\n* Written informed consent given before the enrolment, according to International Conference on Harmonisation\u002Fgood clinical practice (ICH\u002FGCP).\n\nExclusion Criteria:\n\n* Distant metastasis\n* Inability to maintain treatment position\n* Prior radiotherapy to the pelvic region\n* Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)\n* Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)\n* Rectal wall infiltration\n* General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)\n* Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)\n* Severe comorbidities resulting in a prognosis of less than 6 months\n* Inability to give informed consent\n* Other malignancy within the last 5 years\n* Performance status ≥ 2 (ECOG).\n* Significant cardiovascular disease (for example, dyspnea \\> 2 NYHA)\n* Significant systemic diseases grade \\>3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity\n* Women who are pregnant or breast-feeding\n* Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent","80 Years",{"count":227,"type":21},100,[201],"Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma",[28],"2025-12-30",{"date":233,"type":45},"2026-01-02",{"date":235,"type":45},"2017-03-16",{"date":237,"type":21},"2026-12-31",{"name":239,"class":240},"Italian Sarcoma Group","NETWORK",28,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":77,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":53},"100577157","phase-2-pembrolizumab-and-pemetrexed-for-progressive-chordoma-100577157","NCT06794645","Pembrolizumab and Pemetrexed for Progressive Chordoma","A Phase II Study of Pembrolizumab and High-Dose Pemetrexed for the Treatment of Patients With Progressive Chordoma","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet the criteria listed below.\n\n1. Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.\n2. Participant has the willingness to comply with all study procedures and availability for the duration of the study.\n3. Participant has a pathologic diagnosis of chordoma.\n4. Evidence of progressive disease within the past six months before study entry, according to RECIST v1.1.\n5. Participant has measurable disease, according to RECIST v1.1.\n6. Participant is male or female, ≥ 18 years of age.\n7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at study entry:\n\nECOG Performance Status Grade Description 0 Normal activity. Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).\n2. In bed \\\u003C50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.\n3. In bed \\>50% of the time. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.-\n4. 100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n5. Dead.\n\nNote: Special allowance may be made for inclusion of participants with an ECOG PS of 2 if status is due to disease-related impingement of the spinal cord rather than other underlying comorbidities.\n\n8\\. Participant has adequate organ function:\n\n1. ANC ≥ 1.5 x 109\u002FL\n2. Platelets ≥ 100 x 109\u002FL\n3. Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL Note: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n4. Total bilirubin ≤ 1.5 x ULN Note: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 ULN and direct bilirubin within normal limits are permitted.\n5. ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in presence of known hepatic metastasis)\n6. Serum creatinine ≤ 1.5 x ULN 9. Participant has the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDS) 2 days before (5 days for long-acting NSAIDs), the day of, and for 2 days following administration of Pemetrexed.\n\n   10\\. Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to the protocol schedule.\n\n   11\\. Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.\n\n   12\\. Criteria for known Hepatitis B and C positive participant: Hepatitis B screening tests are required.\n\n12.1 Hepatitis B positive participants • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study intervention.\n\n* Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n12.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to study intervention 13. Male participant: agrees to use highly effective contraception as detailed in Section 4.3.2 of this protocol during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.\n\n  14\\. Female participant: meets at least one of the following conditions:\n\n  a. Not a woman of childbearing potential (WOCBP) as defined in Section 4.3.2. OR b. Is a WOCBP who agrees to use highly effective contraception as detailed in Section 4.3.2 of this protocol during the study treatment period and for at least 120 days after the last dose of study intervention.\n\nExclusion Criteria:\n\n4.2 PARTICIPANT EXCLUSION CRITERIA\n\nAn individual who meets any of the following appropriate criteria below will be excluded from participation in this study.\n\n1. Participant has insufficient time from prior therapy to the first dose of study treatment:\n\n   1. Less than 4 weeks for an investigational agent or investigational device\n   2. Less than 3 weeks for major surgery\n   3. Less than 2 weeks for radiation therapy\n   4. Less than 3 weeks for a cytotoxic agent\n   5. Less than 2 weeks or 5 half-lives, whichever is shorter, for a targeted therapy (e.g. tyrosine kinase inhibitor)\n   6. Less than 3 weeks or 5 half-lives, whichever is shorter, for an antibody-based therapy\n2. Participant has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention.\n\n   Note: Please refer to Section 6.4 for information on COVID-19 vaccines.\n3. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n4. Participant has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n   Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n5. Participant has an active bacterial infection requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection.\n6. Participant has a known history of non-infectious pneumonitis or currently has pneumonitis.\n7. Participant has a known history of human immunodeficiency virus (HIV) infection.\n8. Participant has concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\n   Note: Hepatitis C screening is not required unless the participant has a known history of HCV infection.\n9. Participant has had an allogenic tissue\u002Fsolid organ transplant.\n10. Participant has third space fluid which cannot be controlled by drainage. Note: For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing. However, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy.\n11. Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention, including, but not limited to:\n\n    1. Uncontrolled diabetes;\n    2. Renal disease that requires dialysis;\n    3. Pulmonary disorder requiring supplemental oxygen to keep saturation \\>95% and the situation is not expected to resolve within 2 weeks;\n    4. Severe dyspnea at rest or requiring oxygen therapy;\n    5. Interstitial lung disease;\n    6. History of major surgical resection involving the stomach or small bowel;\n    7. Preexisting Crohn's disease;\n    8. Ulcerative colitis;\n    9. Uncontrolled vasculitis and\u002For disease with known vasculitis;\n    10. Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;\n    11. Psychiatric illness, substance abuse, or other social situation that would interfere with cooperation with the requirements of the trial.\n12. Participant has a personal history or presence of any of the following cardiovascular conditions:\n\n    1. Syncope of cardiovascular etiology;\n    2. Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);\n    3. Myocardial infraction within 6 months of investigational product administration;\n    4. Unstable angina;\n    5. Sudden cardiac arrest;\n    6. Congestive heart failure (NYHA classification ≥ 3):\n\n    New York Heart Association Functional Classification Class Patient Symptoms I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).\n\n    II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).\n\n    III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.\n\n    IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.\n13. Participant has a known additional malignancy that is progressing or has required active treatment with the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, organ confined prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n14. Participant is a woman of childbearing potential (WOCBP) who is pregnant or nursing.\n\n    Note: WOCBP should only be included after a negative highly sensitive urine or serum pregnancy test.\n15. Participant has a history of severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients (L-histidine, polysorbate 80, or sucrose).",{"count":250,"type":21},21,[80],"Primary Objective:\n\n1\\. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed.\n\nSecondary Objectives:\n\n1. To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment.\n2. To determine disease control rate based on imaging and overall survival.\n3. To determine median PFS and PFS rates at 6, 9, 12, and 18 months.\n4. To evaluate changes in volumetric tumor measurements based on imaging.\n5. To determine the effects of combination treatment on quality of life, assessed by the EORTC-QLQ-C30 questionnaire.\n6. To assess tumor evolution over time in patients with chordoma based on imaging, and molecular profiling.\n7. To assess the pharmacodynamic effects of treatment in blood.\n\nExploratory Objective:\n\n1\\. To explore the relationship between molecular phenotype and patient response.",[254,28],"Chordomas",[256,257,258],"Pembrolizumab","Pemetrexed","High-Dose Pemetrexed","2025-01-21",{"date":261,"type":45},"2025-01-27",{"date":263,"type":21},"2025-01",{"date":265,"type":21},"2026-11-30",{"name":267,"class":110},"Saint John's Cancer Institute",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":77,"phases":278,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":53},"100518336","analysis-of-the-toxicity-and-efficacy-of-daily-1-vs-2-beam-proton-therapy-100518336","NCT06029218","Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy","Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy : Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy","P1V2","Inclusion Criteria:\n\n* Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy\n* Tumour requiring 2 beams\n* MRI less than one month old\n* PS 0-2.\n* Patient who has read the patient information note and signed the consent form.\n* Patient with healthcare insurance cover.\n* Age over 18 years.\n* For women of childbearing age, negative urine pregnancy test and effective contraception in place for the duration of treatment and for six months following the end of treatment.\n\nExclusion Criteria:\n\n* Persons deprived of their liberty or under guardianship.\n* Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons.\n* Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017\u002F745 of the European Parliament and of the Council of 5 April 2017.",{"count":277,"type":21},106,[201],"Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.",[28,149,94,93],[282],"protontherapy","2024-09-23",{"date":285,"type":45},"2024-09-25",{"date":287,"type":45},"2023-09-13",{"date":289,"type":21},"2031-10-01",{"name":291,"class":110},"Centre Antoine Lacassagne",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":303,"conditions":304,"keywords":309,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100426408","image-assisted-optimization-of-proton-radiation-therapy-in-chordomas-and-chondrosarcomas-100426408","NCT04832620","Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas","Defining Optimal Imaging Strategies for Diagnosis, Treatment, and Treatment Evaluation of Chordomas and Chondrosarcomas of the Axial Skeleton","CHIPT","Inclusion Criteria:\n\n* Histologically diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton (clivus, spine and sacrum)\n* Accepted for standard proton beam therapy\n\nExclusion Criteria:\n\n* Diagnosis other than chordoma or chondrosarcoma is made.\n* Patient refuses (parts) of the standard treatment protocol.\n* Patient refuses MRI due to claustrophobia.\n* Patient not suitable for MRI due to the presence of MRI incompatible implants.\n* Incapacitated patients.\n* Patient doesn't allow coded data to be used for analysis.\n* Patient is under 50 years of age.\n* Lesion size less than 1cm.\n* Patients with WHO 3 and higher.","50 Years",{"count":302,"type":21},40,"Rationale: Chordomas and chondrosarcomas located in the axial skeleton are malignant neoplasms of bone. These tumors share the same clinical challenges, as the effect of the disease is more a function of their local aggressiveness than their tendency to metastasize (20% metastasize). The local aggressive behavior can cause debilitating morbidity and mortality by destruction of nearby located critical neurovascular structures. Imaging has, in addition to histopathology, a role in diagnosis and in guiding (neo)adjuvant and definitive treatment. Despite the low sensitivity to radiotherapy, proton radiotherapy has been successfully used as an adjunct to resection or as definitive treatment for aggressive chordomas and chondrosarcomas, making it a standard indication for proton therapy in the Netherlands.\n\nChordomas and chondrosarcomas consist, especially after previous therapy, of non-viable and viable tumor components. Identification of these viable components by functional imaging is important to determine the effect of previous therapy, as change in total tumor volume occurs more than 200 days after change of functional imaging parameters.\n\nObjective: The main objective of this study is to determine if functional MRI parameters change within 6 months, and earlier than volumetric changes after start of proton beam therapy. This would allow timely differentiation between affected and unaffected (viable) tumor components, which can be used for therapy adjustment.\n\nSecondary objectives: Determine which set of parameters (PET-CT and secondary MRI) can predict clinical outcome (tumor specific mortality, development of metastases, morbidity secondary to tumor activity and morbidity secondary to treatment); determine what type of imaging can accurately identify viable tumor nodules relative to critical anatomical structures; improving understanding of relevance of changing imaging parameters by correlating these with resected tumor.\n\nStudy design: Prospective cohort study Study population: LUMC patients diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton. A number of 20 new patients per year is expected.\n\nMain study parameters: Volumetric and functional MR imaging parameters including permeability parameters.\n\nSecondary parameters are generated by PET-CT (SUV, MTV and TLG), MR (perfusion, permeability and diffusion), therapy (proton beam dose mapping, surgery) and clinical outcome. End points are disease specific survival, progression free survival (including development of metastases), side effects of treatment, and functional outcome (see CRF). In patients who are treated with surgical resection following neo-adjuvant therapy, the surgical specimen will be correlated with imaging findings.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment and clinical management will not be affected in this study, thus the additional burden, risks, and benefits associated with participation in this study are minimal.\n\nTwo extra MRI and one PET-CT examination will be planned during proton therapy.",[305,28,149,306,307,308],"Bone Neoplasm of Vertebral Column","Magnetic Resonance Imaging","PET-CT","Proton Therapy",[28,149,310,307,311],"MRI","Proton therapy","2023-11-15",{"date":314,"type":45},"2023-11-18",{"date":316,"type":45},"2021-02-02",{"date":318,"type":21},"2027-12",{"name":320,"class":110},"Leiden University Medical Center",2]