[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampullary-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampullary-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,73,177],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100499240","individualized-dose-escalation-of-5-fu-for-gastrointestinal-cancer-100499240",false,"NCT05780684","Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer","Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of metastatic or locally advanced\u002Finoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)\n* Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration\n* ECOG Performance Status: 0-1\n\nExclusion Criteria:\n\n* Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)\n* Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)\n* Known mismatch repair deficiency or microsatellite instability-high disease\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening\n* Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator\n* Any of the following baseline laboratory abnormalities:\n\n  * Absolute neutrophil count (ANC) \\\u003C 2,500\u002Fmm3\n  * Platelet count \\\u003C 100,000\u002Fmm3\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Creatinine \\> 1.5 x ULN\n  * Total bilirubin \\> 1.5 x ULN\n  * AST\u002FALT \\> 5 x ULN\n  * Patients who are unable to provide informed consent\n  * Patients who are pregnant or breastfeeding\n  * Patients who are incarcerated, homeless, or have active substance use disorders","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.",[26,27,28,29,30],"Colorectal Cancer","Esophagus Cancer","Appendix Cancer","Small Bowel Cancer","Ampullary Cancer","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":37,"type":35},"2023-07-14",{"date":39,"type":20},"2027-12",{"name":41,"class":42},"Dartmouth-Hitchcock Medical Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100477481","pilot-comparing-ctdna-idv-vs-spv-sample-in-pts-undergoing-biopsies-for-hepatobiliary-and-pancreatic-cancers-100477481","NCT05497531","Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers","Pilot Trial Comparing Circulating Tumor DNA (ctDNA) From Immediate Draining Vein vs. Standard Peripheral Vein Sample in Patients Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers","Inclusion Criteria:\n\n* 18 years of age or older\n* Have or are undergoing work-up for hepatobiliary and\u002For pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)\n* Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion\n* Must be able to provide a written informed consent\n\nExclusion Criteria:\n\n* Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes\n* Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)\n* Patients with uncorrectable coagulopathy\n* Platelet count \\\u003C 30,000\u002Ful\n* International Normalized (INR) \\> 1.5\n* Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage\n* No clear reachable target for percutaneous or trans-jugular biopsy\n* Patient who cannot have a peripheral blood draw for ctDNA",{"count":52,"type":20},15,[23],"This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.",[56,57,58,59,30,60],"Hepatobiliary Cancer","Pancreatic Cancer","Hepatocellular Carcinoma","Cholangiocarcinoma","Pancreatic Carcinoma",[62,63,57,56],"ctDNA","Circulating Tumor DNA","2026-02-23",{"date":66,"type":35},"2026-02-24",{"date":68,"type":35},"2022-09-07",{"date":70,"type":20},"2026-06",{"name":72,"class":42},"University of California, Irvine",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":43},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":82,"type":20},360,[23],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,28,30,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,27,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[163,164,165,166,167],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":170,"type":35},"2026-02-20",{"date":172,"type":35},"2021-10-05",{"date":174,"type":20},"2027-03-16",{"name":176,"class":42},"Cedars-Sinai Medical Center",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":195,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":43},"100599197","phase-3-neoadjuvant-vs-upfront-surgery-for-resectable-pancreatic-cancer-and-periampullary-cancer-100599197","NCT07081360","Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer","Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).\n* Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging:\n\nNo involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery .\n\nLess than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein\u002Fsplenic vein confluence No evidence of metastatic disease.\n\n* Eastern Cooperative Oncology Group (ECOG)=0-1 \\& American Society of Anesthesiologists (ASA) score \\\u003C4.\n* Written informed consent.\n* Medical history without previous pancreatic resection or pancreatic cancer.\n* Adequate organ function (liver, kidney, bone marrow) (serum creatinine ≤2.0 mg\u002FdL,reference range 0.5-1.20 mg\u002FdL; serum albumin ≥2.5 g\u002FdL, reference range 3.5-5.3; aspartate aminotransferase (AST) ≤95 U\u002FL, reference range 0-38; Alanine aminotransferase (ALT) ≤102 U\u002FL, reference range 0-41; prothrombin time ≤1.8, reference range 0-1.20; partial thromboplastin time ≤1.8, reference range 0.82-1.25; leukocyte count greater than 3.5×109\u002FL, reference range 4.2-9.0; platelet count greater than 100×109\u002FL, reference range 130-400; hemoglobin ≥9 g\u002FdL, reference range 12-16).\n\nExclusion Criteria:\n\n* Borderline resectable or locally advanced pancreatic or periampullary cancer.\n* Tumor at the body or tail of the pancreas.\n* Distant metastases.\n* Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.\n* Severe comorbidities precluding surgery or chemotherapy.\n* Pregnancy or lactation.\n* Other neoplastic diseases (malignant)diagnosed in the past 5 years.\n* Major surgery or traumatic event in the past 28 days.","75 Years",{"count":186,"type":20},262,[188],"PHASE3","Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer (PC) patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesions which are not being detected in early disease status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting.\n\nThere are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and periampullary cancer and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC and periampullary Cancer.\n\nThis randomized controlled trial compares neoadjuvant chemotherapy followed by surgery versus upfront surgery for patients with clearly resectable pancreatic head cancer and periampullary cancer. The study aims to determine if neoadjuvant chemotherapy improves overall survival compared to immediate surgery followed by adjuvant chemotherapy.",[91,191,192,193,30,194],"Periampullary Cancer","Periampullary Carcinoma Resectable","Pancreatic Cancer Resectable","Pancreas Adenocarcinoma",[196,197,198],"Pancreatic cancer","Neoadjuvant chemotherapy","Pancreaticoduodenectomy","2025-08-24",{"date":201,"type":35},"2025-08-29",{"date":203,"type":35},"2025-07-20",{"date":205,"type":20},"2028-08-20",{"name":207,"class":42},"Minia University"]