Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study
TRICOMA
1 other identifier
interventional
30
1 country
1
Brief Summary
More than 4200 new cases of colorectal cancer (CRC) are diagnosed each year in Denmark, and 30.000 patients live with the diagnosis. Up to 40% of CRC patients will have synchronous liver metastases (LM) at the time of the diagnosis or will develop metachronous LM during the course of their disease. CRC-LM are treated with a combination of chemotherapy and liver surgery, but less than 25% of the referred patients with CRC-LM may be treated with curative intend. If looking at population-based data this figure drops to less than 5%. During pre-operative chemotherapy the treatment response is monitored by CT and MR scans, and the patients are then discussed on multidisciplinary team (MDT) conferences. However, monitoring is inaccurate since the simple measurement of size of the liver lesions cannot provide reliable evidence of the treatment response. The cancer cells may actually have been replaced by scar tissue but without any shrinkage. The question is how may we improve the evaluation of treatment response? With the goal of improving the assessment of the response to chemotherapy, and thereby only treat the patients that will benefit from chemotherapy?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedStudy Start
First participant enrolled
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFebruary 23, 2018
February 1, 2018
1.7 years
February 9, 2017
February 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue biopsy
Is it possible to obtain a representative laparoscopic (LAP) specimen/biopsy of the marked tissue after chemotherapy?
through study completion, an average of 2 months
Secondary Outcomes (2)
Fiducial marker
through study completion, an average of 2 months
RECIST
through study completion, an average of 2 months
Study Arms (1)
Biopsi arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with non-resectable liver metastasis based on a MDT evaluation and the consensus guidelines regarding oncological and technical resectability criteria
- Expected survival \> 6 months (with chemotherapy)
- Informed consent
You may not qualify if:
- \. Unfit for chemotherapy and/or laparoscopic evaluation 2. History of other malignant diseases 3. Contraindications to general anesthesia or laparoscopic access (e.g. history of massive abdominal adhesions).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nicolaj Markus Stilling
Odense, Danmark, 5000, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 23, 2018
Study Start
May 12, 2017
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
February 23, 2018
Record last verified: 2018-02