{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2021"],"data_sharing_plan":["IPD Sharing (as of October 2021): Yes\nDescription: Completely anonymized IPD will be shared. All dates, HIPEC center treatment, referral city, and personal identification will be removed.\nTime frame: To be shared at the time of phase 3 trial publication. Available for 10 years.\nAccess Criteria: Access by request only from the corresponding author. Study protocol, SAP, ICF will be publicly available without request.\nAdditional information available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code"],"condition":["Colorectal Cancer","Hyperthermia","Metastatic colorectal cancer","Fever","Peritoneal Metastases"],"disease":["Metastatic Colorectal Cancer","Colorectal Cancer","Hyperthermia","Fever","Peritoneal Metastases"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2375587"],"location":["Sweden"],"study_start_month":["5"],"keyword":["Irinotecan","Oxaliplatin","Fluorouracil"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy of Hyperthermic Intraperitoneal Chemotherapy","description":"A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of 200 ml each and injected through two abdominal drains that are clamped for 16 hours.\nFor dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the following group of patients.\nTo study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).","dates":{"creation":"2021-05-15"},"accession":"2375587","cross_references":{"ClinicalTrials___gov":["NCT04861558"],"EU Clinical Trials Register":["2020-005210-18"]}}