[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chondrosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chondrosarcoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,77,107,132,160,206,233,260,285,324,350,374,404],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100442316","phase-1-iacs-6274-with-or-without-bevacizumab-and-paclitaxel-for-the-treatment-of-advanced-solid-tumors-100442316",false,"NCT05039801","IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors","A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors","Inclusion Criteria All Parts\n\n1. Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.\n3. Histologically or cytologically confirmed advanced solid tumors, specifically:\n\n   Dose Escalation for Part A may include:\n\n   Patients with tumors harboring actionable KEAP1\u002FNFE2L2\u002FSTK11\u002FNF1 mutations Patients with low ASNS expression levels (HGSOC or endometrial cancer) Patients who had immunotherapy (IO) melanoma (Minimum treatment duration of prior PD-1 or PD-L1-containing regimen of 12 weeks \\[or equivalent of 2 response evaluations\\]).\n\n   Patients with post-platinum HNSCC Patients with chondrosarcoma Patients with ARID1A mutant clear cell ovarian cancer\n\n   Dose Escalation for Part B may include:\n\n   Confirmed recurrent high-grade non-mucinous ovarian cancer that is platinum-resistant, defined as disease relapse within a platinum-free interval (PFI, or the time elapsed from the last date of platinum dose until PD) of \\\u003C 6 months, and with less than 5 prior therapies\n\n   Dose Expansion for Part B limited to:\n\n   Confirmed recurrent high-grade non-mucinous ovarian cancer with low ASNS expression levels that is platinum-resistant, defined as disease relapse within a PFI of \\\u003C 6 months, and with less than 5 prior therapies.\n\n   Dose Escalation for Part C may include:\n\n   Patients with tumors harboring actionable KEAP1\u002FNFE2L2 mutations Patients with tumors harboring PIK3CA hotspot mutations, activating AKT mutations, and inactivating PTEN mutations (irrespective of KEAP1\u002FNFE2L2 mutations) Patients with low ASNS expression levels (HGSOC)\n\n   Dose Expansion for Part C limited to:\n\n   Patients with NSCLC with actionable KEAP1\u002FNFE2L2 mutations Patients with HGSOClow ASNS expression levels (irrespective of biomarker status for KEAP1\u002FNFE2L2)\n4. Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing therapy(ies) known to provide clinical benefit for their condition.\n5. Prior treatment with chemotherapy, radiotherapy, immunotherapy or any investigational therapies must have been completed at least 3 weeks or at least five half lives, whichever is shorter, before the study drug administration, and all AEs (excluding alopecia and peripheral neuropathy) have either returned to ≤Grade 1 or stabilized. Patients with concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) are allowed.\n6. Fresh and\u002For archival tumor tissue from a biopsy obtained between the completion of the most recent line of treatment until study entry must be available for mutation and biomarker analysis. If available, archival tumor tissue from the time of initial diagnosis or the most recent biopsy (archival and\u002For fresh) will be collected. For ovarian cancer patients, a fresh biopsy must be collected in addition to archival tumor tissue. NOTE: No fresh tumor tissue will be required if a previous biopsy detected the selected mutations for each cohort. In all cases, procedures to obtain fresh tumor tissue should not put the patient at undue risk, and should only be performed if the risk is minimal (no greater than 2% risk of serious or severe complications).\n7. Patients must have at least 1 lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessments.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n9. Adequate organ function as indicated by the following laboratory values:\n\n   Absolute neutrophil count (ANC) ≥1.0×109\u002FL Platelets ≥100×109\u002FL Hemoglobin ≥9.0 g\u002FdL (\\>5.59 mmol\u002FL) Creatinine clearance (CrCl) \\>50 mL\u002Fmin. Actual body weight should be used for calculating creatinine clearance using the Cockroft Gault equation (except for patients with body mass index \\>30 kg\u002Fm2 when the lean body weight should be used, and without the need for chronic dialysis therapy).\n\n   Serum total bilirubin ≤1.5×ULN (with the exception of patients with known thalassemia minor mutations or Gilbert's syndrome: serum total bilirubin must be \\\u003C3×ULN in these patients) Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) ≤2.5×ULN or ≤5×ULN for patients with liver metastases)\n10. Adequate cardiac function with a left ventricular ejection fraction ≥50%\n11. Female patients of non childbearing potential, who are physiologically incapable of becoming pregnant, are eligible to enter and participate in the study if they:\n\n    have had a hysterectomy, OR have had a bilateral oophorectomy, OR have had a bilateral salpingectomy, OR is postmenopausal (total cessation of menses for ≥2 years, or follicle stimulating hormone ≥50 IU\u002FL).\n12. Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective contraception combined with a barrier method (male condom, female condom, cervical cap, diaphragm with spermicide, or contraceptive sponge with spermicide) of contraception starting before entering the study and until 4 weeks after the last dose of treatment.\n\n    Highly effective non-hormonal contraceptive methods that are acceptable include:\n\n    Total\u002Ftrue abstinence\\*\\*\\* for the total duration of the study treatment and for at least 1 month after the last dose of study treatment. Periodic abstinence using methods such as calendar ovulation, symptothermal, post ovulation methods, declaration of abstinence solely for the duration of a trial, or withdrawal are not acceptable methods of contraception.\n\n    Having a vasectomized sexual partner, who received post-vasectomy confirmation of azoospermia, combined with a barrier method as described above.\n\n    Bilateral tubal occlusion combined with a barrier method as described above. Intrauterine device with copper banded coils, combined with a barrier method as described above.\n\n    Highly effective hormonal contraceptive methods that are acceptable include:\n\n    Combined oral pill contraception (normal and low-dose oral pills, or progesterone-based oral pills using desogestrel) combined with a barrier method as described above. NOTE: cerazette is currently the only highly efficacious progesterone-based pill available.\n\n    Injection (e.g., medroxyprogesterone) combined with a barrier method as described above.\n\n    Patch (e.g., norelgestromin or ethinyl estradiol transdermal system) combined with a barrier method as described above.\n\n    Implants (etonorgestrel-releasing) combined with a barrier method as described above.\n\n    Intravaginal device (e.g., ethinyl estradiol- or etonogestrel-releasing) combined with a barrier method as described above.\n\n    Intrauterine system (levonorgestrel-releasing) combined with a barrier method as described above.\n\n    In addition to the to use one form of highly effective contraception combined with a barrier method, female patients of childbearing potential must have a negative serum pregnancy test at screening (within 7 days of the start of treatment) and must not be breastfeeding.\n13. Non-sterile men, who are not sexually abstinent and intend to be sexually active with a woman of childbearing potential, must use a condom from the start of the trial and until 16 weeks after the last dose of treatment, or must practice total abstinence\\*\\*\\* for the total duration of the study treatment and at least 3 months after the last dose of study treatment. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female partners of childbearing potential should consider the use of at least one contraception method describe above. If the female partner is pregnant, male participants should use a condom plus spermicide.\n\n    * Total\u002Ftrue abstinence is defined as a patient who refrains from any form of sexual intercourse, and this is in line with their usual and\u002For preferred lifestyle.\n\nExclusion Criteria All Parts\n\n1. Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.\n2. Known primary central malignancy or symptomatic central nervous system metastasis(es).\n\n   Note: Patients with stable, previously treated brain metastases may participate if neurologic symptoms have resolved, patients have been off steroids (at least 7 days for Part A and Part B, and at least 4 weeks for Part C), and there is no evidence of disease progression by imaging for at least 2 weeks before the first dose of study treatment.\n3. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:\n\n   1. Any unstable cardiac arrhythmia within 6 months prior to enrolment\n   2. Prolongation of the Fridericia corrected QT (QTcF) interval defined as \\>450 ms for males and \\>470 ms for females\n   3. History of any of the following cardiovascular conditions within 6 months of enrolment:\n\n      * cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.\n4. Major surgical intervention within 28 days before study drug administration, or an anticipated need for major surgery during the study.\n5. Significant acute or chronic infections.\n6. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n7. Treatment with strong cytochrome P450 subtype 3A4 (CYP3A4) inducers and inhibitors (including grapefruit juice) within 2 weeks of the first dose of study drug NOTE: patients must have stopped taking St. John's Wort 3 weeks prior to the start of treatment and stopped taking enzalutamide 4 weeks prior to the start of treatment.\n8. Treatment with strong CYP450 subtype 2D6 (CYP2D6) inhibitors or sensitive CYP3A4 substrates within 7 days of the first dose of study drug.\n9. Radiotherapy within 4 weeks prior to the start of study drug. Palliative radiotherapy for symptomatic control is acceptable if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned.\n10. Underlying medical conditions (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), for which in the investigator's opinion will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or AEs.\n11. History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the compounds in the study.\n12. Known history of alcohol or drug abuse.\n13. Legal incapacity or limited legal capacity.\n14. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses (such as refractory nausea and vomiting, chronic gastrointestinal disease or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretionof IACS-6274 and capivasertib, which are oral agents.\n15. Patients unwilling to comply with protocol requirements related to the assigned part.\n16. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n\nPart B Specific Exclusion Criteria (B1) Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, three or more features of partially controlled asthma).\n\n(B2) Patient has a known hypersensitivity to paclitaxel or bevacizumab components or excipients.\n\n(B3) Patient has a history of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.\n\n(B4) Patient has proteinuria as demonstrated by urine protein:creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate \\\u003C2 g of protein in 24 hours to be eligible).\n\n(B5) Patient is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n\n(B6) Patient has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident \\[CVA\\]) within 6 months of enrollment. (B7) Patient has pre-existing peripheral neuropathy that is Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.\n\n(B8) Patient requires paracentesis 2 weeks prior to trial enrolment. Part C Specific Exclusion Criteria (C1) History of another primary malignancy, except for a malignancy treated with curative intent, with no known active disease ≥5 years before the first dose of treatment, with low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy.\n\n(C2) Patient has a known hypersensitivity to capivasertib components or any excipients of the product.\n\n(C3) Clinically significant abnormalities of glucose metabolism as defined by any of the following: Diagnosis of diabetes mellitus type I or II (irrespective of management), Glycosylated haemoglobin (HbA1c) \\>8% (64 mmol\u002Fmol) (C4) Patients with evidence of severe or uncontrolled systemic liver disease including severe hepatic impairment, or abnormal liver enzymes at screening (AST or ALT \\>2.5 x ULN; total bilirubin \\>1.5 x ULN).\n\n(C5) Patients with elevated alkaline phosphatase (ALP) can be enrolled if the abnormal value is due to the presence of bone metastasis, but liver function is considered adequate according to the principal investigator.\n\n(C6) Patients with persistent toxicities (Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment may be included after consultation with the sponsor and the study physician.\n\n(C7) Patients with spinal cord compression or leptomeningeal disease not requiring steroids for at least 4 weeks prior to start of study intervention.\n\n(C8) Patients with clinically significant cardiovascular disease including, but not limited to, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident \\[CVA\\]) within 6 months of enrollment. In addition, patients will be excluded based on the study physician's judgment of the following criteria:\n\n* Mean resting corrected QT interval \\>470ms, obtained from triplicate ECGs performed at screening.\n* Medical history significant for arrhythmia that is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation regardless of treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be included based on the study physician's judgment.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia of Grade ≥1, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relative, history of QT prolongation associated with other medications that required discontinuation of the medication.\n* Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association Grade ≥2.\n* Uncontrolled hypotension: SBP \\\u003C90 mmHg and\u002For DBP \\\u003C50 mmHg.\n* Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n\n(C9) Patients with active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) are excluded.\n\n(C10) Patients with active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening are excluded.\n\nHuman immunodeficiency virus (HIV) positive patients with a viral load \\> 400 copies\u002FmL and a CD4+ T-cell count of \\\u003C350 cells\u002FuL or with a history of an acquired immunodeficiency syndrome (AIDS) opportunistic infection within the past 12 months are excluded. Patients with a higher viral load or lower CD4+ count (\\\u003C 350 cells\u002FuL) may be considered for eligibility if the patient has a potentially curable malignancy or for interventions in a later stage of development that have demonstrated prior activity with a given cancer.\n\nHIV-positive patients receiving antiretroviral therapies should be on established ART for at least four weeks before starting treatment to ensure that treatment is tolerated and that toxicities are not confused with investigational drug toxicities. HIV-positive patients receiving antiretroviral therapies that are strong CYP3A4\u002F5 inhibitors\u002F inducers or sensitive substrates of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib.\n\n(C12) Patients who are undergoing any concurrent anticancer treatment or any concomitant medication that may interfere with the study drugs according to local clinical guidelines are excluded.\n\n(C13) Patients who received palliative radiotherapy within 2 weeks prior to the start of study treatment; or radiotherapy to more than 30% of the bone marrow within 4 weeks before the start of study treatment are excluded.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"Advanced Endometrial Carcinoma","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Malignant Solid Neoplasm","Advanced Melanoma","Advanced Ovarian Clear Cell Adenocarcinoma","Chondrosarcoma","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Recurrent Ovarian High Grade Serous Adenocarcinoma","Refractory Endometrial Carcinoma","Refractory Head and Neck Squamous Cell Carcinoma","Refractory Melanoma","Refractory Ovarian Clear Cell Adenocarcinoma","Refractory Ovarian High Grade Serous Adenocarcinoma","Stage III Ovarian Cancer AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","RECRUITING","2026-05-29",{"date":67,"type":68},"2026-06-01","ACTUAL",{"date":70,"type":68},"2021-09-30",{"date":72,"type":20},"2028-06-30",{"name":74,"class":75},"M.D. Anderson Cancer Center","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100319721","assessment-of-healing-and-function-after-reconstruction-surgery-for-bone-sarcomas-100319721","NCT03442465","Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas","Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone","Inclusion Criteria:\n\n* All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK\n* Current or prior history of primary neoplasms involving osseous structures, including all subtypes\n* Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue\u002Fslides\n* Patients must read and understand English\n* Age \\>\u002F=4\n* Patients must read and understand English\n\nExclusion Criteria:\n\n* Patients that weight \\\u003C17 kilograms","4 Years",{"count":86,"type":20},300,"OBSERVATIONAL","The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.\n\nThe study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery",[90,91,31,92,93,94],"Bone Sarcoma","Osteosarcoma","Ewing's Sarcoma","Osseous Sarcoma","Bone Neoplasm",[96,97],"18-014","Memorial Sloan Kettering Cancer Center","2026-04-16",{"date":100,"type":68},"2026-04-17",{"date":102,"type":68},"2018-02-14",{"date":104,"type":20},"2027-02-14",{"name":97,"class":75},5,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"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":116,"type":20},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.",[90,31,119,120,121],"Chordoma","Ewing Sarcoma of Bone","Pelvic Rhabdomyosarcoma","2026-03-11",{"date":124,"type":68},"2026-03-13",{"date":126,"type":68},"2022-01-20",{"date":128,"type":20},"2031-08-30",{"name":130,"class":75},"Mayo Clinic",3,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":139,"enrollmentInfo":4,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":149,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":158,"locationsCount":76},"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.",[143,91,144,31,145,119,146,147,148],"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",[150,151,152,153],"tumor targeted gene therapy","human cyclin G1 inhibitor","cell cycle control","CCNG1 inhibitor","AVAILABLE","2026-03-02",{"date":157,"type":68},"2026-03-04",{"name":159,"class":75},"Aveni Foundation",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100366742","efficacy-and-safety-of-regorafenib-as-maintenance-therapy-after-first-line-treatment-in-patients-with-bone-sarcomas-100366742","NCT04055220","Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","A Multicentre Exploratory Phase II Study Describing the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","REGOSTA","INCLUSION CRITERIA :\n\nI1. Age ≥ 12 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;\n\nI3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:\n\nFor OS, (excepted head and neck localisations), neoadjuvant and\u002For adjuvant chemotherapy should include methotrexate-based regimen for patients \\\u003C 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.\n\nFor non-OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin and\u002For cisplatin-based regimen.\n\nI4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism);\n\nI5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;\n\nI6. Confirmed complete remission or no evidence of disease (for metastatic disease);\n\nPatients with pulmonary micro nodules can be included provided they do not meet the following criteria:\n\n* At least one lung nodule of 10mm or more\n* And\u002For at least two nodules well limited between 6-9mm\n* And\u002For at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.\n\nI7. Life expectancy of greater than 12 months;\n\nI8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status \\\u003C 2 (adult patients) ;\n\nI9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n* Absolute neutrophil count ≥ 1.5 Giga\u002Fl\n* Platelets ≥ 100 Giga\u002Fl\n* Haemoglobin≥ 9 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN\n* Glomerular filtration rate (GFR) ≥30 ml\u002Fmin\u002F1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula\n* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)\n* Bilirubin ≤1.5 X ULN\n* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and\u002For GGT \\\u003C 1.5 x ULN.\n* Lipase ≤1.5 x ULN\n* Spot urine must not show ≥ 1 \"+\"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 \"+\" protein or more, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1000 mg\u002F24 hours\n\nI10. INR\u002FPTT ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care;\n\nI11. Women of childbearing potential and male patients must agree to use adequate contraception (Appendix 4) for the duration of treatment and for 7 months (210 days) in WOCBP or 4 months (120 days) in men sexually active with WOCBP after the last dose of regorafenib;\n\nI12. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization and\u002For urine pregnancy test within 48 hours before the first administration of the study treatment;\n\nI13. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;\n\nI14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;\n\nI15. Patients covered by a medical insurance.\n\nI16. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study.\n\nNON-INCLUSION CRITERIA :\n\nE1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor);\n\nE2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcomas and Ewing soft tissue sarcomas) and chordomas;\n\nE3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization;\n\nE4. Cardiovascular dysfunction:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%,\n* Congestive heart failure ≥ New York Heart Association (NYHA) class 2,\n* Myocardial infarction \\\u003C 6 months prior to first study drug administration,\n* Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),\n* Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration;\n\nE5. Uncontrolled hypertension (systolic blood pressure \\> 150mmHg or diastolic pressure \\> 90 mmHg despite optimal treatment);\n\nE6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;\n\nE7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration;\n\nE8. Ongoing infection \\> Grade 2 according to NCI-CTCAE v5;\n\nE9. Known history of human immunodeficiency virus (HIV) infection;\n\nNota Bene: Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet the following criteria:\n\n1. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;\n2. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);\n3. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \\\u003C 400 copies\u002FmL prior to enrolment;\n\nE10. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy; Nota Bene: Subjects with a history of hepatitis B or C who have normal alanine aminotransferase (ALT) and are hepatitis B surface antigen negative and\u002For have undetectable HCV RNA are eligible;\n\nE11. Dehydration according to NCI-CTC v5 Grade \\>1;\n\nE12. Difficulties to swallow oral medication and\u002For any mal-absorption condition and\u002For any Gastrointestinal (GI) disease that may significantly alter the absorption of regorafenib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);\n\nE13. Patients with seizure disorder requiring medication;\n\nE14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;\n\nE15. Known hypersensitivity to the active substance or to any of the excipients;\n\nE16. Pregnant women, women who are likely to become pregnant or are breast-feeding\n\nE17. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n\nE18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;\n\nE19. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;\n\nE20. Non-healing wound, non-healing ulcer, or non-healing bone fracture;\n\nE21. Patients with evidence or history of any bleeding diathesis, irrespective of severity;\n\nE22. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;\n\nE23. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;\n\nE24. Patients using prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments);\n\nE25.Patients under tutorship or curatorship.",{"count":169,"type":20},168,[171],"NA","Randomized, non-comparative, multicentre exploratory phase II study.\n\nTwo arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study.\n\nThe comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.",[90,91,174,31,175,176,177],"Ewing Sarcoma","Undifferentiated Pleomorphic Sarcoma","Leiomyosarcoma","Angiosarcoma",[179,180,181,182,183,184,185,186,187,188,189,190,91,191,192,193,194,195],"Maintenance therapy","First line therapy","Regorafenib","Randomization","Double-blinded","Placebo controlled","Relapse-free survival","Time to treatment failure","Overall survival","Quality of life","Compliance","Bone sarcoma","Efficacy","Complete response","Tyrosine kinase inhibitor","Multi-target inhibitor","Safety","2026-02-13",{"date":198,"type":68},"2026-02-17",{"date":200,"type":68},"2020-03-03",{"date":202,"type":20},"2026-10-01",{"name":204,"class":75},"Centre Leon Berard",16,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":131},"100545866","a-study-to-evaluate-the-utilization-of-3d-printed-models-in-pre-operative-planning-100545866","NCT06387485","A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning","Inclusion Criteria:\n\n1. Subjects must be at least 13 years of age.\n2. Subjects must have the ability to provide written informed consent.\n3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.\n4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women.\n2. Subjects that have a serious systemic pathology.\n3. Subjects that have clotting disorders.\n4. Subjects that have uncontrolled hypertension.\n5. Subjects that are HIV-positive.\n6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.\n7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).\n8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.","13 Years",{"count":214,"type":20},150,[171],"This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.\n\nPrimary endpoint: Operative time of surgical procedure.\n\nSecondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.\n\nExploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.",[218,31,91,219,220],"Sarcoma, Ewing","Fibrous Histiocytoma","Fibrosarcoma",[222],"bony tumor","2026-02-04",{"date":225,"type":68},"2026-02-06",{"date":227,"type":68},"2024-03-01",{"date":229,"type":20},"2027-07-31",{"name":231,"class":232},"Ricoh USA, Inc.","INDUSTRY",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":76},"100499162","adherence-to-a-personalized-home-exercise-program-in-patients-with-bone-tumor-undergoing-lower-extremity-salvage-surgery-100499162","NCT05779670","Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery","Treatment Adherence to a Personalized Home Exercise Program in Patients With Bone Cancer Undergoing Lower Extremity Resection and Reconstruction","ADER","Inclusion Criteria:\n\n* patients aged 12 years with bone tumor undergoing surgery (resection and reconstruction of the lower limb) and in adjuvant treatment\n* patients under physiotherapy treatment\n\nExclusion Criteria:\n\n* patients with difficulties in understanding the Italian language\n* patients not using digital services","90 Years",{"count":243,"type":20},50,"The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.",[91,174,31,246],"Bone Tumor",[248,249,250],"rehabilitation","home based exercise","bone tumor","2026-02-02",{"date":253,"type":68},"2026-02-03",{"date":255,"type":68},"2023-01-01",{"date":257,"type":20},"2026-12-31",{"name":259,"class":75},"Istituto Ortopedico Rizzoli",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":76},"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.",{"count":268,"type":20},20,[171],"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.",[119,31],[273,274,275,119,31],"Skull base","Protontherapy","Hypofractionation","2026-01-21",{"date":278,"type":68},"2026-01-23",{"date":280,"type":68},"2023-05-24",{"date":282,"type":20},"2033-05-24",{"name":284,"class":75},"Quironsalud",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":297,"conditions":298,"keywords":311,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":76},"100565717","early-phase-1-pet-imaging-of-two-vartumabs-in-patients-with-solid-tumors-100565717","NCT06645808","PET-imaging of Two Vartumabs in Patients With Solid Tumors","The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients With Solid Tumors - a Phase 0, Open Label, PET\u002FCT Molecular Imaging Basket Trial","VARTUTRACE","General Inclusion Criteria:\n\n1. Willing to adhere to the prohibitions and restrictions specified in this protocol.\n2. Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.\n3. Patients aged ≥ 18 years at moment of signing informed consent form.\n4. Life expectancy of \\> 12 weeks.\n5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n6. BMI ≥ 18.0 and ≤ 35.0 kg\u002Fm2 and weight at least 50 kg and no more than 120 kg at screening.\n7. Overtly healthy based on medical history, physical findings, vital signs, ECG at the time of screening, as judged by the Investigator. Note: one retest of vital functions and ECG is allowed within the screening window.\n8. Adequate liver- and kidney function, defined by the following laboratory results obtained during screening visit:\n\n   * AST, ALT, and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN) as determined by the UMCG laboratory reference values.\n   * Serum bilirubin ≤ 2.0x ULN as determined by the UMCG laboratory reference values. Patients with known Gilbert disease who have serum bilirubin level ≤ 3x ULN may be enrolled.\n   * INR or APTT ≤ 1.5x ULN as determined by the UMCG laboratory reference values. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n   * eGFR (based on plasma-creatinine) = \\>30 mL\u002Fmin.\n   * Serum albumin \\>35 g\u002FL.\n9. No other clinically significant laboratory abnormalities as determined by the investigator. Note: one retest of lab tests is allowed within the screening window.\n10. Female patients should be at least 1 year post-menopausal (amenorrhea \\>12 months and\u002For follicle-stimulating hormone \\>30 mIU\u002FmL) at screening or surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation).\n11. Male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control, and must not donate sperm, until 3 months after administration of 89Zr-DFO-N-Suc-scFv (F8 or C9).\n\nMedical inclusion Criteria:\n\nColon Carcinoma:\n\n1. Patients diagnosed with colon carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of colon carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nRectal Carcinoma:\n\n1. Patients diagnosed with rectal carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of rectal carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBone- and soft-tissue sarcoma\n\n1. Patients diagnosed with a bone- or soft-tissue sarcoma stage I-IV, according to AJCC staging for Sarcoma.\n2. Histologically confirmed diagnosis of sarcoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBreast carcinoma\n\n1. Patients diagnosed with breast carcinoma stage I-IV, according to the 8th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of breast carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nLung Carcinoma:\n\n1. Anticipated diagnosis of Non-Small Cell Lung Carcinoma (NSCLC) stage I-IV, according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Neo-adjuvant treatment according to the standard of care.\n\nHead and Neck Squamous Cell carcinoma (HNSCC):\n\n1. Patients diagnosed with HNSCC of the oral cavity, oropharynx, nasal cavity, nasopharynx, hypopharynx and larynx.\n2. Histologically confirmed diagnosis of HNSCC.\n3. Neo-adjuvant treatment according to the standard of care.\n\nOesophageal and gastric carcinoma:\n\n1. Patients diagnosed with oesophagus carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Patients diagnosed with gastric carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n3. Histologically confirmed diagnosis of oesophageal- or gastric carcinoma.\n4. Neo-adjuvant treatment according to the standard of care.\n\nPancreas carcinoma:\n\n1. Anticipated diagnosis of pancreas carcinoma stage I-IV according to the 8th edition of the TNM-classification, based on imaging modalities such as (PET)\u002FCT or based on cytology.\n2. Histologically or cytologically confirmed diagnosis of pancreas carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nBladder carcinoma:\n\n1. Patients diagnosed with invasive bladder carcinoma stage I-IV according to the 7th edition of the TNM-classification.\n2. Histologically confirmed diagnosis of bladder carcinoma.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGlioblastoma:\n\n1. Anticipated diagnosis of a high-grade glioma (glioblastoma, grade 4 according to the WHO classification) based on imaging modalities such as MRI and\u002For CT or a biopsy.\n2. Karnofsky performance status of at least 70%.\n3. Neo-adjuvant treatment according to the standard of care.\n\nGeneral Exclusion Criteria:\n\n1. Behavioral or cognitive impairment or psychiatric disease that, in the investigator's opinion, affects the patient's ability to understand and cooperate with the study protocol.\n2. Insufficient venous access for the study procedures.\n3. Close affiliation with the investigator, e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of surgery or nuclear department of the UMCG,TRACER or affiliates.\n4. Any finding in the medical examinations or medical history giving, in the opinion of the investigator, reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications.\n5. Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device.\n\nMedical Exclusion Criteria:\n\n1. The existence of a second concomitant active malignancy or treatment for a second malignancy within 1 year prior to IMP-administration that is not a solid tumor indication included in the VARTUTRACE study, except for localized basal or squamous cell cancer that has been cured at least 90 days before screening.\n2. Cardiac impairment with an estimated LVEF \\\u003C35 % Prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.\n3. Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate. Note: One retest of vital functions is allowed within the screening window.\n4. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n5. Major surgical procedure other than for the included diagnosis within four weeks before IMP administration. Disease-related procedures, e.g. the placement of a port-a-cath, placement of a drain, ERCP, are allowed.\n6. Current evidence or history of bacterial, viral or fungal infections within 7 days before 89Zr-DFON-Suc-scFv (F8 or C9) administration as judged by the Investigator.\n\n   * T \\> 38.0°C or lab confirmed viral\u002Fbacterial\u002Ffungal infection (PCR) or symptoms suggestive of an infection)\n   * Received oral or IV antibiotics within \\\u003C7 days before administration.\n7. Any planned major surgery within the duration of the study (until follow-up visit) that is not related to the tumor, with the exception of any emergency surgeries.\n8. Prior allogeneic bone marrow transplantation or solid organ transplant.\n9. A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angio-edema or treatment need can be acceptable if deemed not of clinical significance (including allergy to animals or mild seasonal hay fever).\n10. Any other diseases, metabolic dysfunction, physical examination finding, or clinically significant laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.",{"count":294,"type":20},32,[296],"EARLY_PHASE1","VARTUTRACE is a first-in-human PET\u002FCT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).\n\nOncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues.\n\nVAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.",[299,300,301,91,31,302,303,304,305,306,307,308,309,310],"Solid Tumor","Colon Carcinoma","Rectal Carcinoma","Lung Carcinoma","Head and Neck Squamous Cell Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Pancreas Carcinoma","Bladder Carcinoma","Glioblastoma","Soft Tissue Sarcoma (STS)","Breast Cancer",[312,313,314],"Basket-trial","Oncology","Solid tumors","2025-12-19",{"date":317,"type":68},"2025-12-29",{"date":319,"type":68},"2024-12-10",{"date":321,"type":20},"2026-09",{"name":323,"class":232},"Var2 Pharmaceuticals",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":333,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100365588","phase-2-abemaciclib-for-bone-and-soft-tissue-sarcoma-with-cyclin-dependent-kinase-cdk-pathway-alteration-100365588","NCT04040205","Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration","Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration","Inclusion Criteria:\n\n1. Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see exclusion criteria below)\n2. Metastatic or locally advanced disease that is unresectable\n3. There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met:\n\n   1. Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy\n   2. Osteosarcoma (high-grade), Dedifferentiated chondrosarcoma: at least 1 prior anthracycline chemotherapy, alone or in combination, required either as adjuvant, neoadjuvant or in the metastatic setting. If anthracycline chemotherapy is contraindicated, alternative prior first line chemotherapy is acceptable.\n   3. Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.\n4. Age ≥ 18 years.\n5. Provide study specific (step 1) informed consent prior to study entry\n6. Documented CDK pathway abnormality on a commercially available mutation profiling test (Foundation, Tempus xT, etc), if performed previously as part of routine\u002Fstandard care on tumor (metastatic or primary), having at least one of the following (a and\u002For b)\n\n   1. Cyclin D1 (CCND1), cyclin D2 (CCND2), cyclin D3 (CCND3), cyclin dependent kinase 4 (CDK4), and\u002For cyclin dependent kinase 6 (CDK6) amplification\u002Fcopy number gain\n   2. Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) or CDKN2B copy number loss\n7. Provide study-specific (step 2) informed consent\n8. Rb positive confirmed by immunohistochemistry testing of archived tumor tissue specimen (metastatic or primary site) performed centrally at Medical College of Wisconsin Precision Medicine Laboratory.\n9. All subjects must have measurable disease as defined by RECIST 1.1. (See RECIST 1.1 criteria in Appendix 10.\n10. Subjects must also have had evidence of disease progression by RECIST 1.1 within 6 months of enrollment, or newly diagnosed within the last 6 months (refer to step 1 criteria regarding previous lines of therapy).\n11. A washout period of at least 21 days is required between last chemotherapy dose and enrollment.\n12. A washout period of at least 14 days is required between end of radiotherapy and enrollment.\n13. At least 14 days after surgery, and absence of significant wound healing issues that would pose infection risk.\n14. Subjects with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.\n15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n16. Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n\n    * Hemoglobin ≥ 8.0 g\u002FdL\n\n      a. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n    * Platelets ≥ 100 x 10\\^9\u002FL\n    * Total bilirubin ≤ 1.5 x ULN\n\n      a. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.\n    * Aspartate aminotransferase (AST)(SGOT)\u002Falanine aminotransferase (ALT)(SGPT) ≤ 3 x institutional ULN\n    * Renal function (at least one of the following): Estimated Creatinine Clearance (CrCl) ≥ 30 mL\u002Fmin (Cockcroft-Gault), estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula), or actual CrCl as determined by 24-hour urine collection\n17. Female subjects must meet one of the following:\n\n    * Postmenopausal for at least one year before enrollment, OR\n    * Surgically sterile (i.e. undergone a hysterectomy or bilateral oophorectomy), OR\n    * If subject is of childbearing potential (defined as not satisfying either of the above two criteria), must have a negative serum pregnancy test within 21 days of step 2 enrollment AND\n\n      * Agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom with spermicidal agent added, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, OR\n      * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n18. Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    * Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR\n    * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n19. Subjects must be deemed able to comply with the study plan by the local PI.\n20. Ability to swallow oral medications\n\nExclusion Criteria:\n\n1. Diagnosis of well differentiated (WD) or dedifferentiated (DD) liposarcoma\n2. Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).\n3. Subjects who have not recovered (Common Terminology Criteria for Adverse Events \\[CTCAE v5.0\\] Grade ≤1) from the acute effects of chemotherapy (except for residual alopecia or Grade 2 peripheral neuropathy) prior to enrollment, or other toxicity or serious preexisting medical condition(s) (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) that in the opinion of the site PI is expected to preclude participation in this study.\n4. Subjects currently receiving any other investigational agents.\n5. Current ongoing treatment with strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers or inhibitors.\n6. Uncontrolled intercurrent illness including, but not limited to, known ongoing or active bacterial infection (requiring IV antibiotics), fungal infection, detectable viral infection (such as known HIV or active hepatitis B or C) (screening tests is not required for enrollment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. The subject has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n8. Pregnant women and women who are breast-feeding.\n9. Subjects must not have current evidence of another malignancy that requires treatment.\n10. Subjects who received treatment with live attenuated viruses within 30 days prior to eligibility confirmation or might receive the treatment through the duration of the trial.",{"count":332,"type":20},44,[334],"PHASE2","This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects must have intact Rb, identified at the time of screening, by immunohistochemistry testing of submitted tumor specimen. Subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.",[31,91,145],[338,339,31,91,145],"Rb","Retinoblastoma","2025-07-16",{"date":342,"type":68},"2025-07-20",{"date":344,"type":68},"2019-10-07",{"date":346,"type":20},"2027-06-01",{"name":348,"class":75},"Medical College of Wisconsin",4,{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":76},"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":359,"type":20},106,[171],"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.",[119,31,174,91],[364],"protontherapy","2024-09-23",{"date":367,"type":68},"2024-09-25",{"date":369,"type":68},"2023-09-13",{"date":371,"type":20},"2031-10-01",{"name":373,"class":75},"Centre Antoine Lacassagne",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":382,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":385,"conditions":386,"keywords":391,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"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":384,"type":20},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.",[387,119,31,388,389,390],"Bone Neoplasm of Vertebral Column","Magnetic Resonance Imaging","PET-CT","Proton Therapy",[119,31,392,389,393],"MRI","Proton therapy","2023-11-15",{"date":396,"type":68},"2023-11-18",{"date":398,"type":68},"2021-02-02",{"date":400,"type":20},"2027-12",{"name":402,"class":75},"Leiden University Medical Center",2,{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":417,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":76},"100518356","understanding-engagement-trends-in-chondrosarcoma-clinical-trials-100518356","NCT06029478","Understanding Engagement Trends in Chondrosarcoma Clinical Trials","Understanding Engagement Trends in Chondrosarcoma Clinical Trials: Investigating Participation Patterns Among Chondrosarcoma Patients","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n* Diagnosis of chondrosarcoma\n\nExclusion Criteria:\n\n* No diagnosis of chondrosarcoma confirmed\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form",{"count":412,"type":20},500,"Taking part in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.\n\nThis study will admit a wide range of data on the clinical trial experience of chondrosarcoma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chondrosarcoma patients.",[31],[416],"chondrosarcoma","NOT_YET_RECRUITING","2023-09-01",{"date":420,"type":68},"2023-09-08",{"date":422,"type":20},"2024-10",{"date":424,"type":20},"2026-10",{"name":426,"class":232},"Power Life Sciences Inc."]