[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Proton and Heavy Ion Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":174},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,70,94,121,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603372","ultra-hypofractionated-vs-moderately-hypofractionated-proton-therapy-for-early-breast-cancer-after-lumpectomy-100603372",false,"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":20,"type":21},312,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"Breast Cancer","Proton Therapy",[30,31,27,28],"Ultra-Hypofractionated Irradiation","Moderately Hypofractionated Irradiation","RECRUITING","2025-08-14",{"date":35,"type":36},"2025-08-22","ACTUAL",{"date":38,"type":36},"2024-10-10",{"date":40,"type":21},"2029-10-31",{"name":42,"class":43},"Shanghai Proton and Heavy Ion Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100486390","phase-2-carbon-ion-therapy-for-peripheral-non-small-cell-lung-cancer-100486390","NCT05613452","Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer","Prospective Phase II Clinical Study of Carbon Ion Beam Stereotactic Radiotherapy for Peripheral Type Early-stage Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Between the ages of 18 and 80.\n2. ECOG general status score of 0-2 .\n3. Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC\u002FUICC 8th edition).\n4. The location of the tumor belongs to the peripheral type defined in this study (2cm and beyond (≥2cm) from the esophagus, main bronchial tree, spinal cord, heart, great blood vessels, brachial plexus and stomach, and 1cm and beyond (≥1cm) from the chest wall).\n5. Medically inoperable, or patient refuses surgery.\n6. Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109\u002FL, platelet count ≥80 x 109\u002FL, hemoglobin ≥9 g\u002FdL 2). Lung function: FEV1\\>25%, DLCO\\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \\\u003C1.5 times the upper limit of normal value, and AST, ALT\\\u003C2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml \u002Fmin, and urinary protein \\\u003C2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.\n7. Sign the informed consent.\n\nExclusion Criteria:\n\n1. Multiple primary tumors.\n2. Patient fails to comply with the treatment protocol.\n3. Complicated with other malignant tumors that have not been controlled.\n4. Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.\n5. Chest radiation therapy or radioactive particle implantation history.\n6. Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.\n7. Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.\n8. HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.\n9. A history of mental illness may hinder the completion of treatment.\n10. With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.\n11. Other circumstances that the physician considers inappropriate to participate in clinical study.","ALL","18 Years","80 Years",{"count":56,"type":21},43,[58],"PHASE2","To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.",[61],"Non-small Cell Lung Cancer","2025-06-10",{"date":64,"type":36},"2025-06-13",{"date":66,"type":36},"2024-09-29",{"date":68,"type":21},"2026-12-31",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100568181","phase-2-a-prospective-cohort-study-of-proton-and-photon-therapy-for-left-sided-breast-cancer-100568181","NCT06677879","A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.","A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.","Inclusion Criteria:\n\n1. Histologically confirmed invasive breast cancer.\n2. Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:\n\n   1. Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.\n   2. Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.\n3. Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine\u002Ftargeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall\u002Fbreast and regional lymphatic drainage areas.\n4. No distant metastasis.\n5. Age range: 18-80 years.\n6. Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n7. Non-pregnant and non-lactating women.\n8. Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.\n\nExclusion Criteria:\n\n1. Presence of Ductal Carcinoma In Situ (DCIS).\n2. Tumor staging: Patients presenting with T4, N0, or N3c disease.\n3. History of prior radiotherapy to the ipsilateral chest or breast.\n4. Surgical margin status: Margins are either positive or close, defined as:\n\n   Invasive carcinoma within 1 mm of the surgical margin.\n5. Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.",{"count":78,"type":21},780,[58],"The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:\n\n1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?\n2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?",[27],[83,84,85],"breast cancer","proton therapy","photon therapy","2025-05-24",{"date":88,"type":36},"2025-05-30",{"date":90,"type":36},"2024-08-01",{"date":92,"type":21},"2028-07-31",{"name":42,"class":43},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":44},"100471844","ablative-carbon-ion-radiotherapy-with-pencil-beam-scanning-for-locally-advanced-unresectable-pancreatic-cancer-100471844","NCT05424159","Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer","Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer","Inclusion Criteria:\n\n1. Have the ability to sign the written informed consent;\n2. Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;\n3. Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC\u002FUICC Version 8);\n4. The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;\n5. Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);\n6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n7. Adequate bone marrow function (neutrophil count ≥1.5×109\u002FL, platelet count ≥100×109\u002FL, hemoglobin ≥10.0g\u002FdL);\n8. Adequate liver function (total bilirubin \\\u003C1.5 times the upper limit of normal value, aminotransferase \\\u003C2.5 times the upper limit of normal value);\n9. Adequate renal function (serum creatinine \\\u003C2mg\u002FdL, or creatinine clearance \\>50mL\u002Fmin).\n\nExclusion Criteria:\n\n1. Multiple primary pancreatic lesions (\\>1);\n2. Tumor invaded the adjacent digestive tract;\n3. Radiation therapy history;\n4. Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;\n5. The irradiation dose of organs at risk cannot reach the dose constraint;\n6. Other malignant tumors history;\n7. Inability to understand the purpose of treatment or unwillingness\u002Finability to sign informed consent.",{"count":102,"type":21},48,[24],"The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.",[106],"Pancreatic Cancer Non-resectable",[108,109,110,111,112],"Locally advanced unresectable pancreatic cancer","Carbon ion radiotherapy","Phase II clinical trial","Ablative dose","Optimized linear energy transfer","2023-11-30",{"date":115,"type":36},"2023-12-07",{"date":117,"type":36},"2022-07-01",{"date":119,"type":21},"2026-12",{"name":42,"class":43},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":44},"100492479","phase-2-a-prospective-phase-ii-study-for-adjuvant-hypofractionated-intensity-modulated-proton-radiotherapy-for-post-operative-breast-cancer-with-implantation-reconstruction-100492479","NCT05692674","A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction","Inclusion Criteria:\n\n* 1: Patients with pathologically confirmed breast cancer\n\n  2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction\n\n  3: No distant metastasis\n\n  4: Had no chest and breast radiotherapy history\n\n  5: Between the ages of 18 and 80\n\n  6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy\n\n  7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women\n\n  8: The patient must sign the informed consent form for receiving radiotherapy.\n\nExclusion Criteria:\n\n* 1: No pathological confirmation；\n\n  2: Distant metastasis；\n\n  3: Had chest and breast radiotherapy history\n\n  4: Organs at risk could not achieve safe dose\n\n  5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women\n\n  6: Poor general health status, i.e. KPS\\\u003C70, or ECOG\\>2\n\n  7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；\n\n  8: Unable to understand the purpose of treatment or unwilling\u002Funable to sign informed consent.",{"count":128,"type":21},67,[58],"The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.",[27],[83,133,134,135,136],"hypofractionated","proton radiotherapy","implantation reconstruction","postoperative adjuvant radiotherapy","2023-01-11",{"date":139,"type":36},"2023-01-20",{"date":141,"type":21},"2023-01-10",{"date":143,"type":21},"2028-09-01",{"name":42,"class":43},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":44},"100440057","phase-2-functional-image-guided-carbon-ion-irradiation-with-simultaneous-integrated-boost-for-prostate-cancer-100440057","NCT05010343","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of prostate\n* Stage cT1-3N0M0 localized prostate cancer\n* performed PSMA PET\u002FCT and mpMRI before treatment\n* No lymph nodes or distant metastasis\n* Age ≥ 45 and \\\u003C 85 years of age\n* Karnofsky Performance Score ≥70\n* No previous pelvic radiation therapy (RT)\n* No previous prostatectomy\n* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* No pathologically confirmed adenocarcinoma of the prostate\n* Pelvic lymph node metastasis (N1)\n* Distant metastasis (M1)\n* Previous pelvic radiotherapy\n* Previous prostatectomy","MALE","45 Years","85 Years",{"count":156,"type":21},140,[58],"This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography \u002F computed tomography (PET\u002FCT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.",[160],"Localized Prostate Cancer",[162,163,164,165],"carbon ion irradiation","Simultaneous Integrated Boost","PSMA PET\u002FCT","mpMRI","2021-11-12",{"date":168,"type":36},"2021-11-15",{"date":170,"type":36},"2020-10-15",{"date":172,"type":21},"2028-07-01",{"name":42,"class":43},""]