[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100307303":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":28,"responsibleParty":49,"collaborators":27,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":27,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":27,"enrollmentInfo":62,"targetDuration":27,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":27,"overallStatus":31,"whyStopped":27,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL","Eligible candidates will be enrolled according to in-\u002Fexclusion criteria. Two months after colon resection or immediately after adjuvant chemotherapy (if indicated), a standard laparoscopy including peritoneal lavage, peritoneal biopsies and PIPAC treatment with oxaliplatin 92 mg\u002Fm2 will be planned. This procedure will be repeated after another 5 weeks. Follow up CTs after 12, 24 and 36 months will be planned.",[13],"Drug: PIPAC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","PIPAC","PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 46 mg\u002Fm2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml\u002Fs with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion",[9],[21],"Oxaliplatin",[23],{"name":24,"affiliation":25,"role":26},"Martin Graversen, MD","Odense PIPAC Center","PRINCIPAL_INVESTIGATOR",null,[29],{"facility":30,"status":31,"city":32,"state":27,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Odense PIPAC Center, Department of Surgery, Odense University Hospital","RECRUITING","Odense","5000","Denmark","DK",{"type":37,"coordinates":38},"Point",[39,40],10.38831,55.39594,{"lat":40,"lon":39},[43,47],{"name":24,"role":44,"phone":45,"phoneExt":27,"email":46},"CONTACT","+45 30549497","martin.graversen@rsyd.dk",{"name":48,"role":26,"phone":27,"phoneExt":27,"email":27},"Martin Graversen, MD, Ph.D.",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Michael Bau Mortensen","Professor","100307303","phase-2-adjuvant-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-in-resected-high-risk-colon-cancer-patients-100307303",false,"NCT03280511","Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients","Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial","Inclusion Criteria:\n\n* Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated \u002F pT4NanyM0 (UICC 8th edition) \u002F pTanyNanyM1 with radically resected PM including ovarian metastases\n* Performance status 0-1\n* Fertile women must use approved contraceptives (see below)\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Radiologically or clinically proven relapse.\n* Previous cytoreductive surgery (CRS) with HIPEC\n* Other malignant diagnosis within the last 2 years\n* Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)\n* A history of allergic reaction to oxaliplatin or other platinum containing compounds\n* Renal impairment, defined as GFR \\\u003C 50 ml\u002Fmin, (Cockcroft-Gault Equation).\n* Myocardial insufficiency, defined as NYHA class \\> 2.\n* Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).\n* Inadequate haematological function defined as ANC ≤ 1.5 x 109\u002Fl and platelets ≤ 100 x 109\u002Fl.\n* Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.","ALL","18 Years",{"count":63,"type":64},60,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.",[70,71,72,73],"Peritoneum Cancer","Peritoneal Carcinomatosis","Peritoneal Metastases","Colo-rectal Cancer","2022-10-05",{"date":76,"type":77},"2022-10-06","ACTUAL",{"date":79,"type":77},"2017-12-14",{"date":81,"type":64},"2027-03-01",{"name":51,"class":6},1]