None listed
Conditions
Brief summary
This study is looking to perform a double blinded randomised controlled trial for patients with primary colon adenocarcinoma (cancer) with the use of a monoclonal antibody (Labetuzumab) targeting receptors in the liver which may form liver metastases. Who is it for? You may be eligible for this study if you are an adult with suspected or confirmed colon adenocarcinoma (on histopathology) who is undergoing surgical resection at St George Hospital, Sydney. Study details Participants will undergo blood and tissue testing to determine if they are at low or high risk for developing liver metastases of their colon adenocarcinoma. Patients in the high-risk group will be randomly allocated to either an active treatment group, who will receive an intravenous infusion of Labetuzumab every other day during the month following their surgical resection, or a placebo group who will receive infusions of normal saline only. Data regarding the development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer will be collected from all patients in this study. It is hoped that findings from this study will help inform a multicentric, multinational trial investigating this treatment for patients affected by colon cancer that are at risk of it spreading to their liver and causing unresectable or terminal disease to follow.
Interventions
Labetuzumab in Normal saline for the intervention group (in those patient's who are at higher risk of liver metastases from colon cancer - i.e., have an intact or test positive for the CEA PELPK region)
Dosage: 8mg/kg via an intravenous infusion once a week over a three-week period (three doses in total), commencing 6 weeks after surgical resection.
NB: There are no current strategies planned to be used to monitor adherence (as these aren't available currently)
Risk of liver metastases with be
Labetuzumab in Normal saline for the intervention group (in those patient's who are at higher risk of liver metastases from colon cancer - i.e., have an intact or test positive for the CEA PELPK region) Dosage: 8mg/kg via an intravenous infusion once a week over a three-week period (three doses in total), commencing 6 weeks after surgical resection. NB: There are no current strategies planned to be used to monitor adherence (as these aren't available currently) Risk of liver metastases with be determined for each patient by having their primary tumour tested via genetic sequencing of the CEA PELPK region - If intact; they will be classed as 'higher-risk' and if it is mutant variant then they will be classed as 'lower risk;' - These will occur after primary resection as the resected specimen is required for the test. There will also be a non-active participant group who are at lower risk of liver metastases - apart from being involved in the trial for the purposes of having their primary resected tumour tissue being sent for CEA PELPK region genetic sequencing (which would have been negative or mutant) they will be purely observed as per the Cancer Council Australia CR guidelines - and will not be further involved in the Labetuzumab vs placebo RCT part of the trial
Sponsors
St George Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with suspected or confirmed colon adenocarcinoma (on histopathology) who are undergoing surgical resection at St George Hospital, Sydney
Exclusion criteria
Those who would be beyond 6 weeks post-operatively or had previous bowel cancer/resections.
Outcome results
None listed