[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjuvant-radiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjuvant-radiotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,79],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100626362","comparison-of-mastectomy-expander-trial-100626362",false,"NCT07434648","Comparison of Mastectomy Expander Trial","Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial","COMMET","Inclusion Criteria:\n\n* Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n* Female subjects aged ≥ 18 years at time of consent\n* INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND \u002F OR positive genetic counseling for high-risk family history of breast cancer\n* RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction\n* Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.\n* Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan\n* Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding\n\nExclusion Criteria:\n\n* Subject with implanted device that may be affected by magnetic fields (pacemaker)\n* Known presence of HIV, viral hepatitis (patient-reported)\n* Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy\n* The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.","FEMALE","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the \"approved\" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy\u002Fexpander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.\n\nRequested answers:\n\n* how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment,\n* how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants,\n* how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material,\n* which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).",[27,28,29,30],"Mastectomy and Breast Reconstruction","Tissue Expander Based Breast Reconstruction","Adjuvant Radiotherapy","Long Term Outcome",[32,33,34],"breast reconstruction","implant capsular fibrosis","tissue expander comparison","NOT_YET_RECRUITING","2026-02-20",{"date":38,"type":39},"2026-02-25","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2031-12-31",{"name":45,"class":46},"Medical University Innsbruck","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100537006","phase-2-adjuvant-radiotherapy-for-esophageal-squamous-cell-carcinoma-in-the-era-of-immunotherapy-100537006","NCT06272214","Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy","The Role of Adjuvant Radiotherapy in the Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemotherapy Combined With Immunotherapy: A Multi-center, Phase II Randomized Clinical Study","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form, which must be signed before the specified research procedures required by the study are performed.\n2. Subjects in this study are male or female aged ≥18 and ≤75 years at the time of signing the informed consent form.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky Performance Status (KPS) score ≥80 points (see Table 1) at the time of signing the informed consent form.\n4. Histologically confirmed esophageal squamous cell carcinoma.\n5. The initial patient is a resectable or potentially resectable cT3-4N0 or T1-4N+ patient (AJCC 8th edition) who underwent 2 cycles of neoadjuvant immunotherapy and chemotherapy followed by surgical R0 resection, with postoperative pathology not achieving complete response (non-pCR).\n6. Good organ function as determined by the following requirements: a. Hematology (without blood component or growth factor support within 7 days prior to the start of study treatment): i. Absolute neutrophil count (ANC) ≥1.5×109\u002FL (1500\u002Fmm3). ii. Platelet count ≥100×109\u002FL (100,000\u002Fmm3). iii. Hemoglobin ≥90g\u002FL. b. Renal: i. Calculated creatinine clearance rate (CrCl) ≥50 mL\u002Fmin. \\* CrCl will be calculated using the Cockcroft-Gault formula: CrCL (mL\u002Fmin) = {(140 - age) × weight (kg) × F} \u002F (SCr (mg\u002FdL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. ii. Urinary protein \\\u003C 2+ or 24-hour urinary protein quantitation \\\u003C 1.0 g. c. Hepatic: i. Total bilirubin (TBiL) ≤1.5×ULN. ii. AST and ALT ≤2.5×ULN; for subjects with liver metastasis, AST and ALT can be ≤5×ULN. iii. Serum albumin (ALB) ≥28 g\u002FL. d. Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy, and INR and APTT are within the expected range for anticoagulant therapy). e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.\n7. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose (if urine pregnancy test results cannot be confirmed as negative, a serum pregnancy test must be performed, and serum pregnancy test results will be used) and agree to use highly effective contraception continuously for 120 days after the last dose of study drug; the decision to stop contraception after this time point should be discussed with the investigator.\n8. Male subjects who are not surgically sterile and who are sexually active with female partners of childbearing potential must use effective contraception continuously from the screening period through 120 days after the last dose; the decision to stop contraception after this time point should be discussed with the investigator.\n9. Subjects are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Stage IV metastatic esophageal cancer patients with initial diagnosis of metastasis to visceral organs (such as liver, bone, lung, brain, adrenal gland, etc.).\n2. Patients who did not achieve R0 resection after surgery, including R1 and R2 resection.\n3. Patients who achieved complete pathological response (pCR) after surgery.\n4. Patients with a history of chest radiation therapy.\n5. Patients with esophagomediastinal fistula and\u002For esophagotracheal fistula before treatment.\n6. Pregnant or lactating female patients.\n7. Patients who cannot provide informed consent due to psychological, family, social, or other reasons.\n8. Patients with a history of malignant tumors other than esophageal cancer before enrollment, unless it is non-melanoma skin cancer, in situ cervical cancer, or cured early-stage prostate cancer.\n9. Patients who cannot tolerate chemotherapy or radiation therapy due to severe heart, lung, liver, kidney dysfunction, cachexia, etc.\n10. Patients with active autoimmune diseases, a history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism, etc.), a history of immunodeficiency (including HIV-positive test results), or other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation history.\n11. Patients with active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10×4 copies\u002FmL), hepatitis C (positive hepatitis C antibody, with hepatitis C virus RNA (HCV-RNA) level higher than the detection limit).\n12. Patients with a history of immunodeficiency diseases; HIV antibody-positive individuals; those currently using systemic corticosteroids or other immunosuppressive agents for an extended period.\n13. Severe infections occurring within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections treated with systemic anti-infective therapy within 2 weeks before the first dose (excluding antiviral therapy for hepatitis B or hepatitis C).\n14. Known active tuberculosis (TB) or suspected active TB subjects, who should undergo clinical examination for exclusion; known active syphilis infection.\n15. Vaccination with live vaccines or attenuated live vaccines within 30 days before the first dose, or planned vaccination with live vaccines or attenuated live vaccines during the study period, with the use of inactivated vaccines allowed.\n16. A history of interstitial lung disease or non-infectious pneumonitis.\n17. A history of myocarditis, cardiomyopathy, malignant arrhythmias. Patients with unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification ≥2) or vascular diseases (such as aortic aneurysms at risk of rupture) within 12 months before the first dose or other cardiac injuries that may affect the safety assessment of the study drug (such as poorly controlled arrhythmias, myocardial ischemia).\n18. Known psychiatric illness, substance abuse, alcoholism, or drug abuse history.\n19. Local or systemic diseases not caused by malignant tumors; or diseases or symptoms secondary to tumors, which may lead to a higher medical risk and\u002For uncertainty in survival assessment, such as tumor lysis reaction (white blood cell count \\> 20×109\u002FL), cachexia presentation (weight loss \\> 10% in the 3 months before screening), etc.\n20. Any condition considered by the investigator as posing a risk to the subject, interfering with the evaluation of the study drug, or affecting the interpretation of study results.","ALL","75 Years",{"count":57,"type":21},146,[59],"PHASE2","This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0.\n\nEligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1\u002FPDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1\u002FPDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg\u002Fm2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy\u002F25F\u002F5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients.",[29],[63,64,65,66,67],"Esophageal cancer","Surgery","Neoadjuvant","Chemotherapy","Immunotherapy","RECRUITING","2024-07-12",{"date":71,"type":39},"2024-07-16",{"date":73,"type":39},"2024-03-01",{"date":75,"type":21},"2029-03-01",{"name":77,"class":46},"Zhejiang Cancer Hospital",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100479546","phase-3-study-of-early-stage-endometrial-cancer-based-on-molecular-classification-and-traditional-risk-stratification-to-guide-adjuvant-radiotherapy-decisions-100479546","NCT05524389","Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions","A Prospective Multicentre Phase III Randomised Open Clinical Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions","Inclusion Criteria:\n\n1. Women aged 18-75.\n2. Patients with newly histologically confirmed Endometrioid adenocarcinoma.\n3. ECOG score 0-2\n4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy\n5. Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions:\n\n   1. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years\n   2. Stage IA G3, regardless of LVSI status\n   3. Stage IB G1-3, regardless of LVSI status\n   4. Stage II, regardless of tumor grade and LVSI status\n6. Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.\n\nExclusion Criteria:\n\n1. Not FIGO stage I-II.\n2. Residual tumor or positive margin.\n3. Mixed carcinoma, sarcoma or carcinosarcoma\n4. Previous history of malignant tumor\n5. Previous history of pelvic radiotherapy\n6. The interval between surgery and radiotherapy is more than 12 weeks.\n7. With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy",{"count":87,"type":21},624,[89],"PHASE3","The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.",[92,29,93],"Endometrial Cancer","Molecular Classification",[92],"2022-11-20",{"date":97,"type":39},"2022-11-23",{"date":99,"type":21},"2022-12-01",{"date":101,"type":21},"2027-06-30",{"name":103,"class":46},"Peking Union Medical College Hospital"]