PHASE II TRIAL OF FOLFIRI REGIMEN PLUS BEVACIZUMAB ALTERNATED WITH OXALIPLATIN-BASED HEPATIC ARTERIAL INFUSION PLUS DE GRAMONT REGIMEN AND BEVACIZUMAB IN THE TREATMENT OF UNRESECTABLE LIVER METASTASES FROM COLORECTAL CANCER - ND
- Conditions
- RESECTABLE LIVER METASTASES FROM COLORECTAL CANCERMedDRA version: 6.1Level: SOCClassification code 10029104
- Registration Number
- EUCTR2007-003484-45-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
OLDER THAT 18 YEARS (PATIENTS >= YEARS OLD WILL UNDERGO MULTIDIMENSIONAL GERIATRIC ASSESSMENT), HISTOLOGICAL DIAGNOSIS OF CRC RADICALLY PREVIOUSLY RESECTED (METACHRONOUS LIVER METASTASIS) OR STILL IN PLACE (SYNCHRONOUS LIVER METASTASIS), UNRESECTABLE LIVEL METASTATIC DISEASE WITH LIVER PARENCHYMA REPLACEMENT LESS THAN TWO THIRDS, AS ASSESSED BY RADIOLOGICAL IMAGING (CT OR MRI SCANS), WRITTEN INFORMED CONSENT
Are the trial subjects under 18? yes
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
METASTATIC DIFFUSION IN SITES DIFFERENT BY LIVER, PREVIOUS FIRST LINE THERAPY, RECENT MYOCARDIAL INFARCTION OR ACUTE HEARTH DISEASE, GASTRIC OR DUODENAL ULCER, RECENT SURGERY, ACTIVE SECOND NEOPLAM (WITH EXCEPTION OF SKIN AND IN-SITU CERVICAL TUMORS), SEVERE COGNITIVE IMPAIRMENT HAMPERING COMMUNICATIONS WITH THE PHYSICIAN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): TUMOR RESPONSE RATE (RR);Main Objective: TUMOR RESPONSE RATE (RR);Secondary Objective: RESECTABILITY RATE, TREATMENT TOXICITY, PROGRESSION FREE SURVIVAL (PFS) AND OVERALL SURVIVAL (OS), QUALITY OF LIFE
- Secondary Outcome Measures
Name Time Method