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Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study

NCT03444194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-23

No results posted yet for this study

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 The cancer cells may actually have been replaced by scar tissue but without any shrinkage.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?

Conditions

  • Liver Metastasis Colon Cancer

Interventions

PROCEDURE

liver biopsy

Liver biopsy of neoplastic tissue and normal liver tissue.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03444194 on ClinicalTrials.gov