MedTrace Logo

Perioperative Treatment of Resectable Liver Metastases

NCT01540435 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-05-29

No results posted yet for this study

Summary

This randomized, controlled, multicenter, non-comparative phase II trial compares an intensified perioperative treatment of patients with resectable synchronous or metachronous colorectal liver metastases to primary surgery and adjuvant systemic chemotherapy.

Conditions

  • Colon Cancer Liver Metastasis

Interventions

DRUG

Bevacizumab

Bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) + FOLFOXIRI in a biweekly schedule, 6 cycles preoperatively, 6 cycles postoperatively

Sponsors & Collaborators

  • University of Halle Medical Faculty

    collaborator OTHER

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Hans J. Schlitt, Prof. MD · Department of Surgery, University Medical Center Regensburg

  • Hans-Joachim Schmoll, Prof. MD · Department of Internal Medicine IV, University Hospital Halle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540435 on ClinicalTrials.gov