[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614687":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":73,"collaborators":42,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":42,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy","ACTIVE_COMPARATOR","Laparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures.",[13],"Procedure: Heated intra-peritoneal chemotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy","Conventional administration of pressurized\u002Faerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC)",[18],"Procedure: Aerosolized intra-peritoneal chemotherapy",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Heated intra-peritoneal chemotherapy","Mitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +\u002F- 15 day intervals until three doses have been completed.",[9],[26],"HIPEC",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Aerosolized intra-peritoneal chemotherapy","PIPAC will be performed with mitomycin C, 12.5mg\u002Fm2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +\u002F- 15 day intervals until three doses have been completed.",[15],[32],"PIPAC",[34],{"name":35,"affiliation":36,"role":37},"Patrick Wagner, MD","Allegheny Health Network","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","412-359-3731",null,"patrick.wagner@ahn.org",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"AHN Clinical Trial Contact Clinical Trial Contact","clinicaltrials@ahn.org",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Allegheny Health Network West Penn Hospital","RECRUITING","Pittsburgh","Pennsylvania","15224","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-79.99589,40.44062,{"lat":60,"lon":59},[63,64,65,66,69,71],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},{"name":35,"role":37,"phone":42,"phoneExt":42,"email":42},{"name":67,"role":68,"phone":42,"phoneExt":42,"email":42},"Casey Allen, MD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":42,"phoneExt":42,"email":42},"David Bartlett, MD",{"name":72,"role":68,"phone":42,"phoneExt":42,"email":42},"Alexander Shannon, MD",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Patrick Wagner, MD, FACS","Director, AHNCI Division of Complex General Surgical Oncology","100614687","phase-2-heated-versus-aerosol-based-laparoscopic-chemotherapy-for-cancer-that-has-spread-to-the-peritoneum-abdominal-lining-100614687",false,"NCT07282834","Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)","Randomized Phase II Trial of Heated Vs. Pressurized\u002FAerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis","Charlie-2","Inclusion Criteria:\n\n1. Males or females age 18 to 80 years.\n2. Biopsy-proven or clinically suspected peritoneal carcinomatosis\n3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization\n4. Not a candidate for surgical cytoreduction at the time of laparoscopy\n5. Women at least 18 years of age of childbearing potential must have a negative urine\u002Fserum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.\n6. Must be able to read and understand English and consent for themselves\n\nExclusion Criteria:\n\n1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment\n2. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:\n\n   AST\u002FSGOT \\> 2.5 times the upper limit of normal ALT\u002FSGPT \\> 2.5 times the upper limit of normal Total bilirubin \\> 2.5 times the upper limit of normal Hemoglobin \\\u003C 7 gm\u002FdL White blood cell count \\\u003C 3,000\u002F mm3 Platelet count \\\u003C 50,000\u002Fmm3\n3. Any investigational drug use within 30 days prior to enrollment.\n4. Systemic therapy within 14 days prior to randomization\n5. Allergy or medical contra-indication to chemotherapy utilized in this study\n6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery\n7. Pregnant or lactating females.\n8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.","ALL","18 Years","80 Years",{"count":89,"type":90},200,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or \"IP\" chemotherapy).\n\nThe study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.",[96,97,98,99],"Peritoneal (Metastatic) Cancer","Peritoneal Carcinomatosis","Abdominal Cancer","Abdominal Cancer Patients",[101,102,103,32,26,104,105,106,107],"intraperitoneal","peritoneal cavity","mitomycin-C","Heated Intra-Peritoneal Chemotherapy","Pressurized Intraperitoneal Aerosol Chemotherapy","intra-abdominal","cytoreduction","2026-02-25",{"date":110,"type":111},"2026-02-27","ACTUAL",{"date":113,"type":111},"2026-01-05",{"date":115,"type":90},"2040-11",{"name":75,"class":6},1]