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Table 1 In- and exclusion criteria for treatment with imatinib

From: Imatinib treatment of poor prognosis mesenchymal-type primary colon cancer: a proof-of-concept study in the preoperative window period (ImPACCT)

Inclusion criteria Exclusion criteria
- Male or female aged ≥18 years;
- Histologically proven adenocarcinoma of the colon;
- Completed cancer staging with CT-abdomen and CT-thorax/X-thorax according to hospital’s standard of care;
- Confirmed eligibility for surgery with curative intent as deemed by the hospital’s multidisciplinary board review;
- Test positive for CMS4 subtype;
- ≥4 properly stored pre-treatment biopsies for gene expression analysis/ELISA;
- WHO performance status 0 or 1;
- Adequate haematology status and organ function (defined as: normal creatinine clearance (≥60 ml/min (MDRD)), ALAT within 2.5× upper limit of normal (ULN), PT-INR < 1.5, leukocytes >1,5*10^9/L, Hb > 6.0 mmol/L, platelets >100*10^9/L);
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests;
- Provision of written informed consent.
- The presence of synchronous distant metastases;
- Current hospital standard of care dictates that subject should undergo any neoadjuvant therapy;
- Concurrent participation in another clinical trial using any medicinal product, or participation in such a trial in the period of three months prior to the current trial;
- Women who are pregnant, plan to become pregnant or are lactating during the study or for up to 30 days after the last dose of imatinib;
- Known HIV or Hepatitis B/C infection;
- Known symptomatic congestive heart failure;
- Co-morbidity requiring concomitant treatment with drugs that act as strong inducers of CYP3A4 or with drugs with a narrow therapeutic range influenced by imatinib.