[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma---gastroesophageal-junction-gej\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma---gastroesophageal-junction-gej":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100620578","phase-1-combination-of-chemotherapy-and-adaptive-mr-guided-radiotherapy-to-improve-outcomes-in-patients-with-esophageal-adenocarcinoma-100620578",false,"NCT07359443","Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma","Combination of Chemotherapy and Adaptive MR-Guided Radiotherapy to Improve Outcomes in Patients With Esophageal Adenocarcinoma (MERGE): A Phase 1 Dose-Finding Trial","MERGE","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the esophagus or GE- junction (Siewert I or II)\n* Potentially resectable, locally advanced esophageal tumor (cT1bN+, cT2-3, N0-3, M0) based on standard primary staging by EUS and 18F-FDG PET-CT\n* Eligible for neoadjuvant treatment: followed by esophagectomy (as judged by the multidisciplinary tumor board)\n* Eligible for pCT FLOT\n* Tumor length ≤ 10 cm\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Signed informed consent\n* Tumor volume that can be defined on MRI at baseline (T2w and DW-MRI)\n* Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Non-resectable, inoperable or metastatic adenocarcinoma of the esophagus or GE junction\n* Siewert type III tumors\n* Prior (chemo)radiotherapy to the mediastinum\n* Prior esophageal surgery that impedes the ability to perform an esophagectomy\n* Patients with multiple primary carcinomas of the esophagus\n* Patients who meet exclusion criteria for MRI according to the MRI contraindications screening list of the imaging and oncology division of the UMC Utrecht\n\n  \\* Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of primary tumor prior to start of neoadjuvant chemoradiotherapy\n* Pregnant or breast-feeding patients\n* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule before patient registration. Patients in whom it is not in their best interest to participate (in the judgment of the PI)","ALL","18 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Rationale: Esophageal cancer (EC) is the seventh most frequently diagnosed cancer and the sixth leading cause of cancer-related death worldwide. As a result of the late onset of symptoms, most patients with EC present in an advanced stage with a corresponding poor prognosis. Poor disease outcome after surgery alone (5-yr overall survival between 25-40%) prompted many researchers to explore neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant or perioperative chemotherapy (nCT\u002FpCT) approaches.\n\nIn the Netherlands, neoadjuvant chemoradiation has become standard of care for esophageal cancer since publication of the CROSS trial showing a benefit of nCRT over surgery alone for both adenocarcinoma (AC) and squamous cell carcinoma (SCC) (van Hagen et al., 2012). However, the benefit of nCRT was less pronounced in AC, which was also reflected by pathologic complete response (pCR) rates: 23% in AC vs. 49% in SCC. Furthermore, SCC and AC differ in patterns of recurrence after nCRT or chemotherapy. AC is more likely to develop distant metastases while SCC has a predisposition for locoregional recurrences. This difference in response to nCRT and in recurrence pattern indicates that histology-tailored treatment strategies should be explored. In the modern multidisciplinary discussion on the optimal approach to locally advanced adenocarcinoma of the esophagus and junction, both a trimodiality approach or perioperative chemotherapy are acceptable and evidence based. Therefore both are viable options within current guidelines.\n\nAs mentioned above, patients with an AC of the esophagus are especially prone to develop distant recurrences. In addition, response to nCRT is only moderate in AC. Therefore, the investigators hypothesize that the ideal neoadjuvant treatment should consist of adding MR-guided radiotherapy to standard pCT in order to achieve maximum systemic control and achieve maximum local control.\n\nObjective: The main objective of this study is to determine the maximum tolerated dose (MTD) of 5 fractions MRgRT for patients with AC following FLOT therapy. The secondary objectives are feasibility, non-dose limiting toxicity, oncological outcomes and to explore variables for early response evaluation.\n\nStudy design: 6+3 dose-escalation design with 4 radiotherapy dose levels. Study population: Patients with a resectable esophageal adenocarcinoma who are eligible for nCRT and surgery and who are eligible for MRgRT.\n\nIntervention: 5 sequential, homogenous fractions of 4-8 Gy within 2 weeks on the gross tumor volume (GTV) following preoperative FLOT (as part of standard perioperative chemotherapy) using MR-guided online adaptive radiotherapy on the MR-linac. Start in dose level 0, of 5 x 5Gy per patient, and if safe this is increased step-wise to a maximum dose level 3 of 5 x 8Gy per patient.\n\nMain study parameters\u002Fendpoints: The primary endpoint is the incidence of a dose limiting toxicity (DLT). Early DLT is defined as radiation induced esophageal fistula\u002F perforation\u002F hemorrhage\u002F necrosis or tracheal, bronchial or bronchopleural fistula\u002Ftracheal or bronchopulmonary hemorrhage grade ≥ 3 or any non-hematological grade ≥ toxicity, assessed clinically significant and related to the radiotherapy, according to Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 occurring within 16 weeks after the start of radiotherapy and before surgery or postponing of surgery \\> 16 weeks after the end of radiotherapy due to any grade of treatment-related toxicity. Subacute DLT is defined as peri- and\u002For postoperative complications occurring within 30 days after surgery, defined as postoperative anastomotic leakage or pneumonitis ≥ 3b according to Clavien-Dindo.\n\nSecondary endpoints are non-DLT toxicity, the technical feasibility of dose delivery, perioperative complications. and oncological outcomes including R0 resection rate, histopathological tumor response, local and regional recurrence and death from any cause.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The benefits for the patients may include higher probability of complete primary tumor and lymph node metastases response that initially lead to increased survival and could eventually result in organ-sparing treatment programs. Possible risks are mainly esophageal fistula\u002Fperforation and broncho-esophageal fistula or hemorrhage.",[27,28,29],"Esophageal Adenocarcinoma","Esophageal Adenocarcinoma (EAC)","Adenocarcinoma - Gastroesophageal Junction (GEJ)",[31,32,33,34,35],"MR-Guided Radiotherapy","Adaptive Radiotherapy","MR-Linac","Dose Escalation","Phase 1 Trial","RECRUITING","2026-01-13",{"date":39,"type":40},"2026-01-22","ACTUAL",{"date":42,"type":40},"2025-05-21",{"date":44,"type":21},"2028-05-01",{"name":46,"class":47},"UMC Utrecht","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100612967","the-efficacy-and-safety-of-laparoscopic-proximal-gastrectomy-with-lpg-tbrosf-versus-ltg-for-localized-proximal-gastric-cancer-100612967","NCT07260461","The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.","A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.","Inclusion Criteria:\n\n1. Aged from 18 to 75 years old;\n2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;\n3. The tumor was located in the proximal third of the stomach.\n4. ECOG score of 0 or 1;\n5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).\n6. ASA grade I to III;\n7. The preoperative nutritional status of the patients was good without severe malnutrition.\n8. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n2. Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;\n3. Severe respiratory diseases: severe impairment of lung function (FEV1%\\\u003C50%) or chronic respiratory failure;\n4. Severe liver and kidney dysfunction: ALT\u002FAST \\> 3 times the upper limit of normal, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²;\n5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;\n6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.\n7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;\n8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;\n9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);\n10. Pregnant or lactating women;\n11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;\n12. Severe malnutrition before surgery: BMI \\\u003C 16 kg\u002Fm² or albumin \\\u003C 25 g\u002FL;\n13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).","15 Years","75 Years",{"count":59,"type":21},120,[61],"NA","This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.\n\nThe current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux.\n\nThe main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes.\n\nThe study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.",[64,29,65],"Stomach Neoplasms","Gastroesophageal Junction Cancer","NOT_YET_RECRUITING","2025-12-02",{"date":69,"type":40},"2025-12-03",{"date":71,"type":21},"2026-01-01",{"date":73,"type":21},"2028-09-01",{"name":75,"class":47},"First Affiliated Hospital of Wenzhou Medical University"]