[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555513":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":78,"collaborators":37,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":37,"enrollmentInfo":90,"targetDuration":37,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":45,"whyStopped":37,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Southampton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A (lower dose)","ACTIVE_COMPARATOR","10mg\u002Fm2 MMC given intraperitoneal as one single dose at Time 0 of HIPEC",[13],"Drug: Mitomycin c",{"label":15,"type":16,"description":17,"interventionNames":18},"ARM B (higher dose)","EXPERIMENTAL","35mg\u002Fm2 MMC given in fractionated doses :50% at Time 0, 25% at T30 and 25% at T60",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Mitomycin c","Mitomycin is a tumour antibiotic isolated from the broth of Streptomyces species. It has alkylating properties, which results in DNA cross-linking. Once MMC enters the tumour cell, it needs microsomal modification by various enzymes to be transformed into active state; free radicals constituted of semiquinones of MMC are responsible for its cytotoxic effects.\n\nMitomycin is licenced in the UK and recommended by NICE for intraperitoneal chemotherapy.",[9,15],[26],"HIPEC",[28],{"name":29,"affiliation":30,"role":31},"Faheez Mohamed, MBChB, MD, FRCS","Peritoneal Malignancy Unit Hampshire Hospitals NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Chris Wignall","CONTACT","023 8120 5154",null,"C.M.Wignall@soton.ac.uk",{"name":40,"role":35,"phone":36,"phoneExt":37,"email":41},"Karen Martin","K.S.Martin@soton.ac.uk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":37,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust","RECRUITING","Basingstoke","Hampshire","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-1.08708,51.26249,{"lat":54,"lon":53},[57,60,63,64,66,68,70,72,74,76],{"name":58,"role":35,"phone":37,"phoneExt":37,"email":59},"Faheez Mohamed","Faheez.Mohamed@hhft.nhs.uk",{"name":61,"role":35,"phone":37,"phoneExt":37,"email":62},"Sophia Stanford","sophia.stanford@hhft.nhs.uk",{"name":58,"role":31,"phone":37,"phoneExt":37,"email":37},{"name":61,"role":65,"phone":37,"phoneExt":37,"email":37},"SUB_INVESTIGATOR",{"name":67,"role":65,"phone":37,"phoneExt":37,"email":37},"Alexios Tzivanakis",{"name":69,"role":65,"phone":37,"phoneExt":37,"email":37},"Tom Cecil",{"name":71,"role":65,"phone":37,"phoneExt":37,"email":37},"Sanjeev Dayal",{"name":73,"role":65,"phone":37,"phoneExt":37,"email":37},"Gui Han Lee",{"name":75,"role":65,"phone":37,"phoneExt":37,"email":37},"Brendan Moran",{"name":77,"role":65,"phone":37,"phoneExt":37,"email":37},"Vasanth Mark Samuel",{"type":79,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100555513","phase-3-study-to-evaluate-the-non-inferiority-of-low-dose-hipec-versus-high-dose-hipec-in-the-treatment-of-pmp-hipec-pmp-100555513",false,"NCT06513065","Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)","A Single Blinded Randomised Controlled Study to Evaluate the Non-inferiority of HIPEC With Mitomycin C 10 mg\u002Fm2 for 60 Minutes Versus HIPEC With Mitomycin C 35mg\u002Fm2 for 90 Minutes in the Treatment of Pseudomyxoma Peritonei From Perforated Epithelial Mucinous Tumours of the Appendix","HIPEC-PMP","Inclusion Criteria:\n\n1. Clinical and\u002For radiological diagnosis of pseudomyxoma peritonei from a primary mucinous epithelial tumours of the appendix (low and high grade)\n2. The extent of intraperitoneal disease must be deemed to be amenable to complete cytoreduction (CC0-1, i.e. residual disease of \\\u003C 2.5mm in diameter).\n3. Patients aged 16 or more and capable of giving informed consent for the procedures and interventions of the current trial.\n4. ECOG performance status 0-1.\n\n   Exclusion Criteria:\n5. Patients who have previously undergone cytoreductive surgery and\u002For intraperitoneal chemotherapy.\n6. Clinical evidence or suspicion of metastases to sites different than peritoneum or intra-abdominal lymph nodes\n7. Hypersensitivity to the active substance (mitomycin) or its excipients (mannitol, hydrochloric acid, sodium hydroxide)\n8. Patients with conditions which may affect their ability to understand, retain and weigh up the information related to the requirements and consenting process of the study\n9. Women who are pregnant or breastfeeding.","ALL","16 Years",{"count":91,"type":92},176,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","The Investigators are researching how to improve the treatment currently available for patients diagnosed with Pseudomyxoma Peritonei (PMP). This is a rare cancer that usually starts in the appendix and spreads around the abdomen.\n\nPMP is usually treated using a type of surgery called Cytoreductive Surgery (CRS). During the surgery heated chemotherapy will also be used to treat any cancer cells that cannot be seen and may be left behind. This is called Hyperthermic Intraperitoneal Chemotherapy (HIPEC).\n\nThis treatment is commonly used in the UK and in Europe, however, the chemotherapy can be given at two different doses: a lower dose over 60 minutes or a higher-dose over 90 minutes.\n\nThe Investigators want to understand if there is a difference between these two doses. The higher dose has been associated with a slightly increased rate of complications but may be better at killing cancer cells and preventing recurrence of cancer. In Basingstoke the lower dose over 60 minutes is used and survival results are similar to centres who use the higher dose.\n\nPrevious studies have shown that both doses are effective at treating PMP, but no research has shown which is better for patients. The Investigators hope to show that the lower-dose over 60-minutes is as good as the higher-dose over 90-minutes.",[98],"Pseudomyxoma Peritonei",[100,101,102,103],"Psuedomyxoma Peritonei","Mitomycin C","Hyperthermic Intraperitoneal Chemotherapy","Appendix","2026-02-17",{"date":106,"type":107},"2026-02-19","ACTUAL",{"date":109,"type":107},"2024-12-04",{"date":111,"type":92},"2029-04",{"name":5,"class":6},1]