[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463753":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":50,"collaborators":31,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":31,"maxAge":31,"enrollmentInfo":61,"targetDuration":31,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":79,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Imperial College London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant systemic and peritoneal chemotherapy","EXPERIMENTAL","Standard neoadjuvant systemic and pressurised intraperitoneal aerosol chemotherapy",[13],"Drug: Doxorubicin and Cisplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Doxorubicin and Cisplatin","Pressurised intraperitoneal aerosol chemotherapy",[9],[21],"Adriamycin",[23],{"name":24,"affiliation":5,"role":25},"George B Hanna, FRCS, PhD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Piers R Boshier, FRCS, PhD","CONTACT","020 7594 8197",null,"prb03@ic.ac.uk",[34],{"facility":35,"status":31,"city":36,"state":31,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Imperial College London, Hammersmith Hospital Campus","London","W12 0HS","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-0.12574,51.50853,{"lat":44,"lon":43},[47,49],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":48},"g.hanna@imperial.ac.uk",{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"type":51,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100463753","phase-2-neoadjuvant-systemic-and-peritoneal-chemotherapy-for-advanced-gastric-cancer-100463753",false,"NCT05318794","Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer","Neoadjuvant Systemic and Peritoneal Chemotherapy for Regionally Advanced Gastric Cancer With Minimal Peritoneal Disease","SPECTRA","Inclusion Criteria:\n\n* Gastric adenocarcinoma (Tx, Nx) 1,2,3\n* Peritoneal cytology +ve or PCI ≤ 3\n* No solid organ metastasis 2\n* HER2 -ve\n* Male\u002Ffemale\n* Treatment naïve\n* BMI ≥ 18.5 kg\u002Fm2 or ≤ 40 kg\u002Fm2\n* WHO performance status ≤ 1\n* Dysphagia score ≤ 2\n* Informed written consent\n\nExclusion Criteria:\n\n* PCI ≥ 4\n* Solid organ metastasis\n* Positive lymph node disease beyond field of D2 lymphadenectomy\n* Peritoneal adhesions precluding complete laparoscopy\n* Ascites (greater than trace amount)\n* Malignant pleural effusion\n* Mechanical bowel obstruction (with the exception of gastric outlet obstruction)\n* HER2 +ve\n* Patients eligible for immunotherapy\n* Uncontrolled co-morbidity\n* single\u002Fmultiple organ failure\n* BMI \\\u003C 18.5 kg\u002Fm2 or \\> 40 kg\u002Fm2\n* WHO performance status \\> 1\n* Dysphagia score \\> 2\n* Contraindication to chemotherapy\n* Pregnancy or breastfeeding\n* Haemoglobin \\\u003C90 g\u002FdL uncorrected with blood transfusion","ALL",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and\u002For minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis.\n\nExisting data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile.\n\nGiven these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and\u002For minimal peritoneal disease).",[69,70,71],"Gastric Cancer","Peritoneal Metastases","Chemotherapy Effect",[18,73,74,75,76,77,78],"PIPAC","Neoadjuvant therapy","Gastrectomy","Curative","Doxorubicin","Cisplatin","NOT_YET_RECRUITING","2023-09-12",{"date":82,"type":83},"2023-09-13","ACTUAL",{"date":85,"type":63},"2023-11",{"date":87,"type":63},"2030-07",{"name":5,"class":6},1]