Investigating the efficacy of an Adjuvant immunotherapy for preventing colorectal liver metastases - The CCaLM trial
Phase 2
- Conditions
- Colon cancerOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12623001333606
- Lead Sponsor
- St George Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 66
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer[Medical imaging - ultrasound, CT or MRI At 1, 3, 6 then 12 months post operatively, then 6 monthly for 2 years and they yearly for 3 years for a total of at least 5 years; in line with the colorectal cancer guidelines from cancer Australia ]
- Secondary Outcome Measures
Name Time Method Development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer in patients who test negative or have a mutated CEA PELPK region (will be in the non-active participant group)[medical imaging - Ultrasound, CT or MRI; 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 1, 3, 6 and 12 months post operatively, then 6 monthly for 2 years and then yearly for 3 years for a total of at least 5 years]