{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2005"],"condition":["Cancer-Bowel-Back passage (rectum) or large bowel (colon)","Metastatic colorectal cancer"],"disease":["Metastatic Colorectal Cancer","Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2451960"],"location":["Australia"],"study_start_month":["11"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Randomised Phase II trial of irinotecan with hyaluronic acid (HyCAMP) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapy","description":"Interventions: This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently completed Phase I study combining irinotecan with HA.\nPatients will be randomized in a 1:1 fashion to either \n1) HyCAMP (irinotecan and HA) or \n2) Control arm (irinotecan)\nPrimary outcome(s): Incidence of Grade 3 and 4 diarrhoea[]\nStudy Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy","dates":{"creation":"2005-11-15"},"accession":"2451960","cross_references":{"Australian New Zealand Clinical Trials Registry":["ACTRN12605000119695"]}}