[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"appendiceal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:appendiceal-neoplasms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100509457","phase-2-technical-feasibility-of-modified-early-post-operative-intraperitoneal-chemotherapy-mepic-100509457",false,"NCT05913674","Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)","Inclusion Criteria:\n\n* Patient's age 18 years or older, both genders.\n* In good general health as evidenced by an ECOG score of 0 or 1.\n* Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (\\\u003C 12 months after primary diagnosis) or metachronous (\\>12 months after the primary diagnosis)\n* Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate. (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +\u002F- biopsy\n* Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC\n* Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed.\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the study duration\n* Hematology: Absolute neutrophil count (ANC) ≥ 1,500\u002F μL; Platelets \\> 75,000\u002F μL.\n* Adequate Renal function Creatinine \\\u003C1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml\u002Fmin.\n* Adequate Hepatic function: Bilirubin less than 1.5mg\u002FdL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg\u002FdL).\n\nExclusion Criteria:\n\nPre-cytoreductive surgery:\n\n* Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement\n* Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery\n* Known allergic reaction or major toxicity to Fluorouracil\n* Contraindications to Fluorouracil, including history of coronary spasm and\u002For known dihydropyrimidine dehydrogenase deficiency\n* Pregnancy\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy.\n\nPost-cytoreductive surgery:\n\n* Patient deemed not medically suitable to receive mEPIC protocol according to surgical team\n* Uncorrected coagulopathy and\u002For thrombocytopenia and\u002For neutropenia\n* Active infection\n* Hemodynamic and \u002F or respiratory compromise\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate IP therapy.","ALL","18 Years",{"count":18,"type":19},25,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms.\n\nThe primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively.\n\nParticipants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg\u002Fm2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg\u002Fm2) on postoperative days 1 and 2.",[25,26,27],"Peritoneal Carcinomatosis","Appendiceal Neoplasms","Colorectal Cancer Metastatic",[29,30,31,32,33,34],"Intraperitoneal chemotherapy","Early post-operative intraperitoneal chemotherapy","Fluorouracil","Hyperthermic intraperitoneal chemotherapy","Cytoreductive surgery","mEPIC","RECRUITING","2026-05-12",{"date":38,"type":39},"2026-05-14","ACTUAL",{"date":41,"type":39},"2026-05-01",{"date":43,"type":19},"2028-09",{"name":45,"class":46},"Ciusss de L'Est de l'Île de Montréal","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":76,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":47},"100495686","genetics-of-appendix-cancer-study-100495686","NCT05734430","Genetics of Appendix Cancer Study","Genetics of Appendix Cancer: The GAP Study","GAP","Inclusion Criteria:\n\nGAP Social\n\n* Known diagnosis of appendix cancer in the United States\n* Mentally and physically able to consent and participate in the study\n\nGAP Vanderbilt\n\n* Known diagnosis of appendix cancer\n* Diagnosed by and\u002For consulting with a physician\u002Fclinical provider participating in the GAP Study\n* Mentally and physically able to consent and participate in the study\n\nGAP Parent\n\n* Biological parents (mother and\u002For father) of individuals actively participating in the GAP Study\n* Residing in the United States\n* Mentally and physically able to consent and participate in the study\n\nExclusion Criteria:\n\n* Women pregnant at the time of consent\n* Prisoners\n* Unable to provide informed consent\n* Unable to read, write, or complete questionnaires in English",true,{"count":58,"type":19},700,"OBSERVATIONAL","The GAP Study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix\u002Fappendiceal cancer who are ages 18+ years.",[62,63,26,64,65,66,67,68,69,70,71,72,73,74,75],"Appendix Cancer","Appendiceal Cancer","Appendiceal Mucinous Neoplasm","Appendiceal Adenocarcinoma","Appendiceal Carcinoid Tumor","Appendiceal Neoplasm Malignant Secondary","Appendix Adenocarcinoma","Appendix Mucinous Neoplasm","Appendix Tumor","Appendix Cancer Metastatic","Appendix NET","Low-Grade Appendix Mucinous Neoplasm","High Grade Appendix Mucinous Neoplasm","High Grade Appendix Mucinous Adenocarcinoma",[77],"Genetics","2025-04-15",{"date":80,"type":39},"2025-04-18",{"date":82,"type":39},"2022-11-11",{"date":84,"type":19},"2034-11",{"name":86,"class":46},"Andreana Holowatyj, PhD, MSCI"]