Perioperative treatment with COI-E (capecitabine, oxaliplatin, irinotecan and cetuximab) of liver metastasis of colorectal carcinoma potentially resectable although at high risk of recurrences - ND

• Conditions: Patients affected by colorectal metastases to the liver only (stage IV-liver only) defined as potentially resectable although at high risk of recurrence according to INT-MILAN internal guidelines.

• Registration Number: EUCTR2008-001062-93-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Histological diagnosis of colorectal adenocarcinoma.
-Potential resectability of liver metastases by major liver surgery according to at least one of the following criteria: Portal embolization preceding resection; ?two stage epatectomy? of any kind; tumor involvement of more than 1 hepatic vein; tumor involvement of > 4 hepatic segments
-Should those criteria not apply, inclusion will be extended to regular candidates to liver resection carrying at least one of the following adverse prognosis factors: > 4 metastatic nodules; CEA > 200 U/L; synchronous metastases
-Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
-Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
-An interval of at least 3 weeks must be allowed from resection of the primary tumour
-Age > 18 years
-Performance Status (ECOG <2)
-Adequate organ function
-Patients must sign an informed consent document (ICD)
-Male and female patients with reproductive potential must use an approved contraceptive methods.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Primitive tumour in situ
-Extra hepatic metastatic disease
-Tumor involvement of liver > 70%
-Chance of a liver remnant after surgery < 25%
-More than 6 hepatic segments involved
-Eligibility for concurrent radiotherapy treatment
-Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
-Previous treatment with more than 3 months of FOLFOX or FOLFIRI
-Previous therapy with bevacizumab
-Body Mass Index > 35
-Brain metastases
-Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn`s disease or ulcerative colitis
-Previous dangerous life threatening toxicities from fluoropirimidine
-Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the activity of the preoperative regimen with regards to overall response rate (ORR). Tumour response assessment will be performed by the investigator per modified-RECIST criteria.;Secondary Objective: -To assess the efficacy of the perioperative treatment in terms of time to recurrence (TTR) following surgery, time progression free survival (PFS), overall survival (OS), and disease free survival (DFS).<br>-Pathology Tumor Response Rate and Resectability Rate, with particular reference to safe resection in terms of percentage of liver remnant in relation to body weight (LRBWR: liver remnant body weight ratio).<br>-To evaluate tolerability of the chemotherapy regimen added with cetuximab during both preoperative and postoperative phases.;Primary end point(s): Perioperative treatment with COI-E (capecitabine, oxaliplatin, irinotecan and cetuximab) of liver metastasis of colorectal carcinoma potentially resectable although at high risk of recurrences