[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proton-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proton-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,80,105,133,161,189,221,248,271],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100434220","virtual-reality-for-children-in-radiotherapy-rever-100434220",false,"NCT04934293","Virtual Reality for Children in Radiotherapy (REVER)","REVER","Inclusion Criteria:\n\n* Patient treated at the Antoine LACASSAGNE Center for treatment by proton therapy\n* Age ≥ 7 years old and ≤ 18 years old\n* Patient, and parents for minor children, having read the information notice and signed the informed consent,\n* Patient with social security coverage.\n\nExclusion Criteria:\n\n* Age \\\u003C 7 years old and \\> 18 years old,\n* Patient under general anesthesia,\n* Patient suffering from wounds or infections in the head, deemed incompatible with the use of the helmet by the investigator,\n* Patient suffering from respiratory problems,\n* Patient suffering from a high level of claustrophobia,\n* Patient followed for a psychiatric pathology,\n* Patient suffering from unbalanced epilepsy,\n* Patient suffering from visual (binocular vision) and \u002F or hearing disorders preventing the use of virtual reality,\n* Patient whose head circumference is insufficient for the use of the helmet, deemed incompatible with the use of the helmet by the investigator,\n* Patient treated by radio chemotherapy.","ALL","7 Years","18 Years",{"count":20,"type":21},47,"ESTIMATED","INTERVENTIONAL",[24],"NA","For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment.\n\nA fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought.\n\nRelaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions.\n\nWe will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy.\n\nMultiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.",[27,28,29],"Virtual Reality","Proton Therapy","Pediatric Cancer","RECRUITING","2026-05-27",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":34},"2021-08-02",{"date":38,"type":21},"2027-02",{"name":40,"class":41},"Centre Antoine Lacassagne","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100633910","phase-1-proton-based-total-marrow-irradiation-for-allogeneic-transplantation-in-high-risk-amlmds-100633910","NCT07532824","Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML\u002FMDS","Proton Total Marrow Irradiation-Based Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation in High-Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome","UHKT-PTC-TMI-1","Inclusion Criteria:\n\n1. Underlying diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS),\n\n   A) Acute Myeloid Leukemia (AML), meeting at least one of the following criteria:\n\n   i. Relapsed disease after a prior complete remission (CR) or\n\n   ii. Disease refractory to at least two cycles of intensive chemotherapy or\n\n   iii. High-risk AML in complete remission (CR), defined by at least one of the following:\n\n   iii a) Adverse molecular or cytogenetic risk according to ELN 2022 classification or\n\n   iii b) Presence of measurable\u002Fminimal residual disease (MRD).\n\n   B) Myelodysplastic Syndrome (MDS), meeting at least one of the following criteria:\n\n   i. Relapsed MDS with increased blasts (MDS-IB) or\n\n   ii. MDS-IB2 without reduction of bone marrow blasts below 10% after induction chemotherapy or after at least two cycles of azacitidine or\n\n   iii. IPSS-M score \\> 0.5 (high-risk or very high-risk disease).\n2. Eligibility confirmed by the institutionalal Transplant Indication Committee according to standard criteria.\n3. Age ≥ 18 years and ≤ 65 years\n4. Ability to understand and voluntarily sign written informed consent\n\nExclusion Criteria:\n\nSevere comorbidity, defined as the presence of one or more of the following conditions:\n\n1. Left ventricular ejection fraction (LVEF) \\\u003C 40%\n2. Creatinine clearance \\\u003C 0.5 mL\u002Fs\n3. Total bilirubin \\> 40 µmol\u002FL (unless attributable to Gilbert's syndrome or hemolysis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN)\n4. Pulmonary function impairment defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \\\u003C 50% of predicted value, or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C 50% of predicted value after correction for anemia\n5. Karnofsky Performance Status \\\u003C 70%\n6. Active viral hepatitis or human immunodeficiency virus (HIV) infection\n7. Presence of liver cirrhosis\n8. Pregnancy","65 Years",{"count":53,"type":21},16,[55,56],"PHASE1","PHASE2","This is an open-label, single-center, non-randomized phase I\u002FII pilot study evaluating proton-based Total Marrow Irradiation (TMI) as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult patients with high-risk or relapsed\u002Frefractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These patients have an unfavorable prognosis with standard conditioning approaches.\n\nParticipants will receive a standard conditioning regimen consisting of either myeloablative or reduced-intensity chemotherapy, selected according to age and comorbidities, combined with proton TMI delivered at a total dose of 12 Gy in three fractions. Graft-versus-host disease (GvHD) prophylaxis will be administered according to institutional standards, preferentially using post-transplant cyclophosphamide. Patients will subsequently undergo standard allo-HSCT and will be followed for at least 24 months after transplantation.\n\nThe primary objective of the study is to assess the safety and tolerability of proton TMI added to standard conditioning, as measured by non-relapse mortality and treatment-related toxicity within the first 100 days after transplantation. Secondary objectives include evaluation of engraftment kinetics, incidence of relapse, overall and relapse-free survival, GvHD outcomes, and quality of life. Study outcomes will be analyzed descriptively and compared with a matched historical cohort.",[59,60,28,61,62],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)\u002FAML","MDS and AML Prior to Allogeneic SCT","Myelodysplastic Neoplasm",[64,65,66,28,67,68,69],"High-Risk Hematologic Malignancy","Total Marrow Irradiation","TMI","Conditioning Regimen","Targeted Radiotherapy","HSCT","2026-04-09",{"date":72,"type":34},"2026-04-16",{"date":74,"type":34},"2025-11-21",{"date":76,"type":21},"2029-11",{"name":78,"class":41},"Institute of Hematology and Blood Transfusion, Czech Republic",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":79},"100431173","preoperative-proton--radiotherapy-combined-with-chemotherapy-for-borderline-resectable-pancreatic-cancer-100431173","NCT04894643","Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer","PARC","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer\n* Diagnosis of borderline resectable cancer according to the international consensus definition 2017.\n* Negative staging for distant metastasis\n* Blood test within the following limits absolute neutrophil count \\> 1,500 cells\u002Fmm³, platelet count \\> 100,000 cells\u002Fmm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C 2.5 times the upper limit of normal, total bilirubin \\\u003C 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin \\\u003C 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine within normal range (0.6-1.5 mg\u002Fdl) with a creatinine clearance \\> 30 ml\u002Fmin (as estimated by Cockroft Gault equation)\n* Age \\> 18 years\n* Karnofsky index ≥ 70\n* No tumor infiltration of stomach or duodenum\n* The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol)\n* Women of fertile age must have adequate conception prevention measures and must not breast feed\n* Signed Informed Consent (must be available before study inclusion)\n\nExclusion Criteria:\n\n* Non-exocrine tumors\n* Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery\n* Presence of distant metastasis\n* Pregnancy or unwilling to do adequate conception prevention\n* Lactating and unwilling to discontinue lactation\n* Men of childbearing potential not willing to use effective means of contraception\n* Known allergic\u002Fhypersensitivity reaction to any of the components of study treatments\n* Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study\n* Metallic prosthesis or other condition that prevent an adequate imaging for target volume definition\n* Loco-regional conditions that contraindicate radiotherapy e.g. active infections in the area\n* Previous abdominal radiotherapy\n* Prior systemic treatment for pancreatic cancer\n* Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy\n* Severe hepatic impairment\n* Baseline Neutrophil Counts \\\u003C 1.5 x 10\\^9\u002FL\n* Baseline Grade ≥ 2 sensory or motor neuropathy\n* Patient refusal",{"count":5,"type":21},[24],"This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.",[91,28],"Pancreatic Cancer",[93,94],"Proton therapy combined with chemotherapy","Borderline Resectable Pancreatic Cancer","2026-03-19",{"date":97,"type":34},"2026-03-20",{"date":99,"type":34},"2020-09-14",{"date":101,"type":21},"2027-12-31",{"name":103,"class":104},"EBG MedAustron GmbH","INDUSTRY",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":114,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":42},"100617332","humanitas-protontherapy-hu-pro-100617332","NCT07317245","HUmanitas PROtontherapy (HU-PRO)","HU-PRO","Inclusion Criteria:\n\n* Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations\n* Written informed consent for HU-PRO according to applicable legal and ethical requirements\n* Indication for proton therapy\n* ≥ 18 years old\n* ECOG PS (performance status scale) 0-2\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* ECOG (performance status scale) \\>3\n* Life expectancy \\\u003C 3 months\n* Inability to provide informed consent",{"count":113,"type":21},500,"10 Years","OBSERVATIONAL","Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area.\n\nHowever, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy.\n\nAt present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.",[118,28],"Cancer",[120,121,122,123],"registry","cancer","proton therapy","re-irradiation","2026-01-19",{"date":126,"type":34},"2026-01-21",{"date":128,"type":34},"2026-01-12",{"date":130,"type":21},"2036-01",{"name":132,"class":41},"Istituto Clinico Humanitas",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100508049","long-term-cognitive-and-functional-impact-of-proton-therapy-or-modern-fractionated-radiotherapy-in-cavernous-sinus-meningioma-an-open-label-randomized-11-phase-iii-study-100508049","NCT05895344","Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study","Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma","COG-PROTON-01","Inclusion Criteria:\n\n* Cavernous sinus meningioma for which clinical target volume is larger than 3 centimeters\n* Anterior skull base meningioma, invading by contiguity the cavernous sinus can be included\n* Histologic proven Grade I meningioma\n* Meningioma for which biopsy is not safely achievable and for which growing and imaging criteria are in favour of grade I meningioma can be included\n* Age \\>18 years and ≤70 years\n* Indication of irradiation validated by a pluridisciplinary meeting\n* Adjuvant or exclusive irradiation is allowed.\n* Use of conventional fractionation: 1.8Gy (RBE)\u002Ffraction\n* Signed informed consent form\n* WHO Performance status equal to 0 or 1\n* Patient affiliated to the French social health insurance\n* MoCA score ≥ cut-off of GRECOGVASC normative data (Roussel, 2016, cf annexe 1)\n* Patient whose neuropsychological abilities allow to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Patient with mutation in a known predisposition gene (NF-2, SMARCE-1…)\n* Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease and other dementias, organic psychosis (other than dementia), schizophrenia, and neurodegenerative disease\n* Radiosurgery, hypofractionated regimen\n* Other localization than cavernous sinus\n* Histologic proven Grade II or III meningioma\n* Patient with unadjusted antiepileptic drug\n* Contraindication to MRI\n* Patient with a history of brain irradiation\n* Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)\n* Pregnant\u002Fbreastfeeding woman\n* Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial for less than 30 days\n* Patient deprived of freedom or under guardianship","70 Years",{"count":143,"type":21},160,[24],"Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.\n\nThe doses delivered to these structures are crucial and radiotherapy of cavernous sinus meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy, cognitive impairment…). In 2012, Gondi reported that a dose given to 40% of the bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.\n\nThere is no published or recruiting prospective study evaluating the impact of proton-therapy or conventional irradiation on neurocognitive function for meningioma patients. Notably, long-term cognitive or ocular impact of these modern irradiation schemes remains poorly known. Yet, these patients had a long life-expectancy, and are at risk of developing long-term sequelae. Thus, according to its ballistic advantage, an improvement of patient functional outcomes and a reduction of neurocognitive long-term toxicity are expected if tissue sparing proton-therapy is used.\n\nIn this context, a randomized prospective study, evaluating long-term toxicity of these two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems crucial to further assess proton-therapy indication for these patients.\n\nAlthough literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight retrospective studies found in the literature used an accurate and full evaluation of long-term toxicity",[147,148,149,150],"Cavernous Sinus Meningioma","Proton-therapy","Photon Radiotherapy","Cognitive Impairment","2025-09-24",{"date":153,"type":34},"2025-09-29",{"date":155,"type":34},"2024-02-26",{"date":157,"type":21},"2032-08",{"name":159,"class":41},"Centre Francois Baclesse",13,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":169,"minAge":170,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":42},"100603372","ultra-hypofractionated-vs-moderately-hypofractionated-proton-therapy-for-early-breast-cancer-after-lumpectomy-100603372","NCT07135661","Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy","A Prospective Phase II Randomized Controlled Trial Comparing Ultra-Hypofractionated and Moderately Hypofractionated Proton Radiotherapy Following Breast-Conserving Surgery in Early-Stage Breast Cancer（UPH-BC）","UPH-BC","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma\n3. Breast conserving surgery + sentinel lymph node biopsy\u002Faxillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)\n4. No distant metastasis confirmed by CT, MRI, bone scan, and PET\u002FCT\n5. No prior radiation therapy to the ipsilateral chest or breast\n6. ECOG 0 \\~ 2 or KPS ≥ 70\n\nExclusion Criteria:\n\n1. Without pathology diagnosis\n2. Positive margins or close margins (\\\u003C 2mm)\n3. Lymph nodes or distant metastasis\n4. Bilateral breast cancer or patients with a history of contralateral breast cancer\n5. Prior radiation therapy to the ipsilateral chest or breast\n6. Pregnancy (confirmed by serum or urine β-HCG test) or lactation","FEMALE","40 Years",{"count":172,"type":21},312,[24],"Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy\u002F5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy\u002F25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment. The FAST-Forward trial demonstrated comparable 5-year ipsilateral breast tumor recurrence rates (IBTR) and incidence of radiation-related toxicities between ultra-hypofractionated whole-breast irradiation (UH-WBI; 26 Gy in 5 fractions over 1 week) and moderately hypofractionated whole-breast irradiation (MH-WBI; 40 Gy in 15 fractions over 3 weeks). Additionally, no statistically significant difference in cosmetic outcomes was observed between the two regimens at the 2-year follow-up.\n\nProton radiotherapy enables precise dose delivery to tumor targets while minimizing radiation exposure to surrounding normal tissues, thereby reducing treatment-related toxicities. However, current clinical protocols predominantly employ conventional fractionation for proton therapy, with a paucity of robust evidence evaluating the efficacy and safety of ultra-hypofractionated proton radiotherapy in breast cancer patients. This prospective randomized controlled trial aims to establish high-level scientific evidence for the clinical application of ultra-hypofractionated proton radiotherapy following BCS, ensuring non-inferiority in oncologic control, toxicity profiles, and cosmetic preservation compared to standard regimens.",[176,28],"Breast Cancer",[178,179,176,28],"Ultra-Hypofractionated Irradiation","Moderately Hypofractionated Irradiation","2025-08-14",{"date":182,"type":34},"2025-08-22",{"date":184,"type":34},"2024-10-10",{"date":186,"type":21},"2029-10-31",{"name":188,"class":41},"Shanghai Proton and Heavy Ion Center",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":198,"studyType":115,"phases":4,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":42},"100579637","safety-and-efficacy-of-impt-or-imrt-for-breast-cancer-100579637","NCT06826885","Safety and Efficacy of IMPT or IMRT for Breast Cancer","The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study","SEPPT-BC","Inclusion Criteria\n\n* Aged ≥18 years old\n* Karnofsky Performance Status (KPS) score ≥70\n* Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.\n* ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.\n* Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.\n* Ability to understand and willingness to participate in the research and sign the informed consent form.\n\nExclusion Criteria\n\n* Pregnant or lactating women.\n* Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.\n* Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.\n* Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.",{"count":113,"type":21},"5 Years","The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and\u002For regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.",[176,28,201,202,203],"Intensity Modulated Radiation Therapy","Efficacy and Safety","Radiotherapy, Adjuvant",[205,206,207,208,209,210,211],"postoperative radiotherapy","preoperative radiotherapy","IMPT","IMRT","breast cancer","efficacy","toxicity","2025-02-13",{"date":214,"type":34},"2025-02-14",{"date":216,"type":34},"2024-12-01",{"date":218,"type":21},"2029-11-30",{"name":220,"class":41},"Ruijin Hospital",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100443533","phase-3-proton-versus-photon-therapy-for-esophageal-cancer---a-trimodality-strategy-100443533","NCT05055648","PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy","PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) a Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer","PROTECT","Inclusion Criteria:\n\n* Patients with histologically verified squamous cell carcinoma or adenocarcinoma (including signet cell carcinoma and large cell carcinoma, not further specified) of the esophagus (E) or gastro-esophageal junction (GEJ).\n\n  * FDG PET\u002FCT performed.\n  * Tumor stage according to TNM (8th edition): cT1-4a and\u002For cN+, cM0.\n  * Age ≥18 years.\n  * Performance status WHO ≤2.\n  * Adequate laboratory findings: hematological: hemoglobin \\> 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1,5 x 109\u002FL, platelets ≥ 75 x 109\u002FL hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN, GFR (may be calculated) \\> 30 ml\u002Fmin\n  * MDT decision on suitability to undergo curatively intended nCXT or nCPT followed by surgery.\n  * Planned transthoracic esophagectomy or gastrectomy being open, minimally invasive of combination of both.\n  * Ability to adhere to procedures for study and follow-up.\n  * Patients with low risk cancers with a life expectancy above 5 years (e.g. low risk prostate cancer) are allowed in the study. Adequately treated diagnoses such as cervix uteri carcinoma in situ, in situ urothelial carcinoma or localized non-melanoma skin cancer are allowed, regardless of time of diagnosis.\n  * Patients of childbearing potential: pregnancy prevention according to the standards of each country. Patients of childbearing potential must present a negative pregnancy test. Patients and their partners must use effective contraception. Patients of childbearing potential included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after.\n\nExclusion Criteria:\n\nPatients who meet one or more of the following exclusion criteria cannot be included in the study:\n\n* Prior thoracic XT or PT, chemotherapy or surgical resection in the esophageal\u002Fgastric region (previous EMR or ESD is allowed).\n* Tumor \\\u003C 3 cm from oropharyngeal sphincter.\n* Planned transhiatal resection\n* Patients with other previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.\n* Any unstable systemic disease (including clinically significant lung and cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease).\n* Symptomatic peripheral neuropathy greater than grade 1 (scored according to CTCAE v5.0).\n* Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.\n* Unable to understand and digest study patient information or comply with study treatment and safety instructions.\n* Gastro-esophageal stent within the irradiated volume.",{"count":230,"type":21},396,[232],"PHASE3","The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).",[235,236,237,28],"Esophageal Cancer","Radiotherapy","Side Effect","2024-12-12",{"date":240,"type":34},"2024-12-17",{"date":242,"type":34},"2022-05-01",{"date":244,"type":21},"2032-12-01",{"name":246,"class":41},"University of Aarhus",15,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":169,"minAge":18,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":42},"100551614","phase-2-proton-therapy-for-locally-advanced-cervical-cancer-100551614","NCT06462378","Proton Therapy for Locally Advanced Cervical Cancer","Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  * Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT\n  * Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.\n  * Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines\n  * T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2)\n  * Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB)\n  * Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis\n  * Patient written, informed consent\n  * Age≥18 years\n  * Patients must be able to understand a Danish or Swedish\n\nExclusion Criteria:\n\n* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin\n* Metastatic disease beyond para-aortic region (L1-L2 interspace)\n* Previous pelvic or abdominal radiotherapy\n* Combination of preoperative radiotherapy with surgery\n* Patients receiving neoadjuvant chemotherapy\n* Contra indications to MRI\n* Contra indications to IGABT\n* Contra indications to protontherapy\n* Small cell histology (neuroendocrine tumors)\n* Active infection or severe medical condition endangering treatment delivery\n* Pregnant, lactating or childbearing potential without adequate contraception\n* Human Immune Deficiency Virus (HIV)\n* Patients with no possibility of follow up","99 Years",{"count":257,"type":21},55,[56],"The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.",[261,28,262],"Cervical Cancer","Radiotherapy Side Effect","2024-06-11",{"date":265,"type":34},"2024-06-17",{"date":267,"type":34},"2024-05-20",{"date":269,"type":21},"2034-05-20",{"name":246,"class":41},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":279,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":282,"conditions":283,"keywords":289,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":79},"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":281,"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.",[284,285,286,287,288,28],"Bone Neoplasm of Vertebral Column","Chordoma","Chondrosarcoma","Magnetic Resonance Imaging","PET-CT",[285,286,290,288,291],"MRI","Proton therapy","2023-11-15",{"date":294,"type":34},"2023-11-18",{"date":296,"type":34},"2021-02-02",{"date":298,"type":21},"2027-12",{"name":300,"class":41},"Leiden University Medical Center"]