MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: AVASTIN
Product Name: avastin
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: CAMPTO
Product Name: CAMPTO
Pharmaceutical Form: Powder and solvent for suspension for
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
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 3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL . - Hepatic: bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - Tumor involvement of liver > 75% - Chance of a liver remnant after surgery 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): radiologic response, pfs, safety, overall survival;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public ContactOncologia Medica I
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed