Exploring the Utility of Peritoneal Tumour DNA to Detect Clinically Occult Peritoneal Metastasis in Locally Advanced Colon Cancer (DETECT-PM)
- Conditions
- Colon CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 100
• Histological confirmed colon adenocarcinoma that is amenable to curative intent surgery• Evidence of perforation as determined by imaging or the surgeon at the time of resection. Perforation is defined as tumour perforation, perforation of the efferent bowel, or a peri-tumoural abscess.• For patients without evidence of perforation, clinical T2-T4 tumour of the colon will be enrolled initially, but only those with clinical T4 disease at the time of surgery (as determined by the surgeon at the beginning of surgery) will be eligible for the study• Staging imaging (CT +/- PET) within 8 weeks of surgery showing no metastatic disease.• Patients with synchronous localised peritoneal metastatic disease (detected at the time of surgery) that is fully resected at the time of primary tumour resection will be allowed (maximum 10 patients)• ECOG performance status 0-2• Patients with life expectancy of at least 2 years
• Patients with widespread or unresectable synchronous metastatic peritoneal disease• Patients with a colorectal cancer metastases (non-peritoneal) - resectable and unresectable• Patients with rectal cancer• Patients treated with pre-op radiation or chemo-radiation• Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease or prostate cancer with a Gleason score =6.• Pregnant or lactating women• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is peritoneal recurrence-free survival.[Time-to-event outcomes will be compared using the Cox proportional-hazards model. Peritoneal recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.<br><br>A ctDNA test will be collected pre-surgery, 4-6 weeks post surgery, 12 months post surgery and at recurrence and a peritoneal lavage will be collected at time of surgery to detect ptDNA. In a small cohort of patients, another peritoneal lavage will be collected after treatment. Both the ctDNA and ptDNA tests will not be analysed in real time so will not be used to inform the primary outcome.<br><br>The cut-off date for primary analysis will be when the final patient enrolled has been followed up for 24 months]
- Secondary Outcome Measures
Name Time Method recurrence-free survival,[Recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5. Recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.]; overall survival[Time-to-event outcomes will be illustrated using Kaplan-Meier plots with 95% confidence intervals. Participants will be followed up for survival every 6 months. Participants will be followed up every 6 months for survival status until 5 years post surgery or death whichever occurs first.];time-to-peritoneal recurrence. [Time-to-event outcomes will be compared using the Cox proportional-hazards model. Peritoneal recurrence will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.]