Status:
COMPLETED
Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
Lead Sponsor:
International Group of Endovascular Oncology
Conditions:
Colon Cancer Liver Metastasis
Eligibility:
All Genders
18-70 years
Brief Summary
* The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It ap...
Detailed Description
This is an observational study and the treatment is related to the experiences and economical availability of each center. Primary objective: To collect data on time to progression (local and/or dist...
Eligibility Criteria
Inclusion
- Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)
- Progression of disease after first line therapy containing Irinotecan completed at least one month previously
- Performance status (PS) 0-2
- Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)
- Adequate information and subsequent written informed consent
- Life expectancy \> 3 months
- Patients K-RAS wild type
Exclusion
- Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)
- Brain metastases
- Severe and confirmed vascular diseases
- Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
- Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)
- Known hypersensitivity reactions towards components of the study drugs
- Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives
- Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures
- Patients K-RAS mutant
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01891552
Start Date
May 1 2013
End Date
May 1 2015
Last Update
May 13 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, Italy, 61122