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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003484-45-IT
Enrollment
Unknown
Registered
2007-06-19
Start date
2007-05-25
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

UNRESECTABLE LIVER METASTASES FROM COLORECTAL CANCER MedDRA version: 6.1 Level: SOC Classification code 10029104

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: ELO

Sponsors

ISTITUTO ONCOLOGICO VENETO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026