colon cancer large intestinal cancer
Conditions
Interventions
Patients will be treated with imatinib for two weeks prior to surgery. Imatinib
will be administered orally at 400mg once per day, which is the standard
registered dosage for treatment of CML and GI
Colon cancer
Imatinib
Mesenchymal type
Pre-operative trial
Sponsors
Oncologie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Histologically proven adenocarcinoma of the colon; Confirmed eligibility for surgery with curative intent; High expression of mesenchymal genes determined with diagnostic qPCR test; WHO performance status 0 or 1.
Exclusion criteria
Exclusion criteria: The presence of synchronous distant metastases ; Current hospital standard of care dictates that patient should undergo any neoadjuvant therapy; Concurrent participation in another clinical trial using any medicinal product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed as a proof-of-concept study with multiple outcomes of interest. The primary endpoint is the extent of treatment-induced changes in expression of genes associated with the poor-prognosis mesenchymal subtype. This will be evaluated by comparison of gene expression arrays from paired pre- and post-treatment tissue samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will further assess the relation between the pharmacokinetics of imatinib and the extent of target inhibition and changes in gene expression. Changes in circulating tumour DNA levels will be measured during treatment as a surrogate measure for change in tumour load. Finally, we will to study the effects of imatinib on tumour-derived organoid cultures. | — |
Countries
The Netherlands
Outcome results
None listed