Metastatic colorectal cancer with metastasis confined to the liver MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Irinotecan
Product Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Anni Ravnbek Jensen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Informed consent -Age over 18 years -Performance status 0-1 and remaining life expectancy of> 3 months -Histologically proven adenocarcinoma from the colon or rectum -Either remove the primary tumor or primary tumor is deemed operable -Liver metastases where local treatment is not possible -The presence of liver metastases documented by contrast multiphase CT -Extrahepatic disease not detected -No chemo therapy for at least 6 months (adjuvant) -Liver involvement 1.5 x 109 and platelets> 100 x 109, bilirubin 40 ml / min -INR =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: -Second malignancy except basal cell carcinoma and in situ carcinoma of the cervics uteri -Treatment with other experimental drugs or participation in other trials. -Pre-existing polyneuropathy more than Grade 1 (NCI CTC v. 3) -Other serious medical disease, cardiomyopathy> NYHA II, AMI where aggretions antiplatelet therapy is ongoing. Symptoms of angina pectoris. -Arterial thromboembolic events including transient ischemic attack, or myocardial infarction within 12 months. -Congenital bleeding diathesis or acquired coagulopathy -BMI> 40 -Treatment with St. John's Wort, CYP3A-inducing anticonvulsants or ketoconazole. -Physical or mental illness that would prevent understanding or Compliance -Patients with uncontrolled infection -Pregnant or lactating women. In fertile women, this is done with a negative pregnancy test -Women of childbearing potential not using adequate contraception -Patients of linguistic, intellectual or cultural reasons do not fully understand the treatment concept and respond appropriately to complications and side effects -Sensitivity, to any or several of the known active agents, or adjuvants which form part of the intended treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of drug eluting bead with irinotecan-trans arteriel chemoembolizatin, administered in combination with FOLFOX and bevacizumab, followed by standard treatment with FLIRI and bevacizumab in patients with liver-only metastatic CRC .;Secondary Objective: Engelsk Dansk Tysk -To observe the peripheral concentration of irinotecan and its degradation products during DEBIRI-TACE and FILIRI treatments -To observe whether DEBIRI-TACE causes an angiogenesis-promoting effect by measuring specific biomarkers in serial blood samples and to correlate these biomarkers with clinical endpoints. -To assess tumor blood flow by means of serial dynamic imaging (CT perfusion), and to correlate this with the clinical endpoints.;Primary end point(s): Frequency of surgical resection and / or RFA treatment.;Timepoint(s) of evaluation of this end point: -6 Months after the last patient has completed the study the frequency of surgical resection and / or RFA treatment will be determined | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Response rate, as measured by RECIST 1.1 -Response-duration -Time to progression of liver / extrahepatic, -1 And 5 year survival -The safety profile of the combination of DEBIRI-TACE, FOLFOX and bevacizumab;Timepoint(s) of evaluation of this end point: -6 Months after the last patient has completed the study the safety profile vil be compiled. -12 Months after the last patient has completed treatment, 1 year survival will be determind. -60 Months after the last patient has gennmført treatment or last patient has died, respons duration, TTP, and 5 year survival will be determind | — |
Countries
Denmark
Contacts
Public ContactMartin Jensen
Aarhus Univercity Hospithal
Outcome results
None listed