Chemotherapic treatment before and after curative surgery of colorectal liver metastases

Phase 1

Conditions: Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2013-001362-42-IT

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 46

Inclusion Criteria

- Histological diagnosis of colorectal adenocarcinoma.
- Liver-limited metastases or metastases mainly (=80% total disease burden) limited to the liver with extraepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
-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
-Age >= 18 years
-Performance Status (ECOG <2)
-Adequate organ function including the following:
- Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL .
- Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
- Renal : serum creatinin <2.0xULN
-Patients compliance and geografic proximity that allows for adequate follow-up
-Patients must sign an informed consent document (ICD)
- Male and female patients with reproductive potential must use an approved contraceptive method.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

-Tumor involvement of liver > 75%
-Chance of a liver remnant after surgery < 25%
-Eligibility for concurrent radiotherapic 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 or cetuximab or panitumumab
-Administration of other experimental drugs during the study.
-Body Mass Index > 35
-Brain metastases.
-Pregnancy and breast-feeding.
-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.
-Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration.
-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: major pathologic response;Secondary Objective: radiologic response, pfs, safety, overall survival;Primary end point(s): major pathologic response;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures