Tumour markers response to chemotherapy in patients with colorectal liver metastases
- Conditions
- PATIENTS WITH LIVER COLORECTAL METASTASES NOT CANDIDATED TO SURGERYMedDRA version: 14.1Level: LLTClassification code 10024700Term: Liver metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000834-21-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
COLORECTAL LIVER METASTASES
UNRESECTABLE ACCORDING TO NORTLINGER CLASSIFCIATION (ANN.ONCOL.2009)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
EXTENSION OF DISEASE OUTSIDE THE LIVER
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: COMPLETE LIVER RESECTION AFTER CHEMOTHERAPY;Secondary Objective: TIME TO SURGERY<br>TIME TO PROGRESSION<br>TOLERABILITY<br>RESPONSE RATE <br>OVERALL SURVIVAL;Primary end point(s): COMPLETE RESECTION OF LIVER METASTASES;Timepoint(s) of evaluation of this end point: 4 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): TIME TO PROGRESSION;Timepoint(s) of evaluation of this end point: 24 MONTHS