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Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases

This study has been completed.
Sponsor:
Collaborators:
VU University Medical Center
University Medical Centre Groningen
MMC Hopsital Veldvoven (Department of Surgery)
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00119899
First received: July 6, 2005
Last updated: August 30, 2005
Last verified: August 2005
History of Changes
  Purpose

Objective(s) of the proposed study:

  • The evaluation of the efficiency of 18F deoxyglucose-Positron Emission Tomography (FDG-PET) in staging patients eligible for hepatic resection of colorectal liver metastases in a randomized clinical multicentre setting.

Research questions of the proposed study:

  • What are the effects and costs for patients with liver metastases of colorectal cancer indicated for potentially curative hepatic resection, using the conventional diagnostic strategy with computed tomography (CT) scan in comparison to the experimental diagnostic strategy incorporating FDG-PET scan (CT + FDG-PET scan), based on a health care perspective and a time horizon of 9 months.

More specifically:

  • Does the experimental diagnostic strategy which includes FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases lead to a better disease-free survival at 9 months after hepatic resection in comparison to the conventional diagnostic strategy using CT scan without FDG-PET scan.
  • What are the costs of diagnostic and therapeutic care for the two diagnostic strategies for patients eligible for potentially curative hepatic resection of colorectal liver metastases.
  • What is the effect of including the FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases after hepatic resection, expressed as disease-free survival at 9 months adjusted for quality of health (Q-TWIST), in comparison to the use of CT scan only.

Condition Intervention Phase
Colorectal Liver Metastases
Colorectal Cancer
Neoplasm Metastasis
 Procedure: FDG-PET scan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Disease Free Survival (9 months)
  • Economic evaluation (9 months)

Secondary Outcome Measures:
  • Disease Free Survival
  • Overall Survival
  • Change in Clinical Management
  • Economic evaluation

Estimated Enrollment: 150
Study Start Date: March 2002
Estimated Study Completion Date: June 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One to four colorectal liver metastases on spiral CT, judged potentially resectable by an experienced liver surgeon from the institution participating in the trial.
  • WHO performance status 0, 1 or 2.
  • Age 18-75 years
  • Written informed consent

Exclusion Criteria

  • Evidence of extrahepatic disease as demonstrated by spiral CT scan of chest and abdomen with oral and intravenous contrast with contiguous reconstruction algorithm. In case of previous rectal cancer spiral CT should include the pelvic area. CT readings should be performed by an experienced radiologist from the institution participating in the trial.
  • Signs of recurrent or second colorectal carcinoma on barium enema or colonoscopy.
  • Any other previous malignancy other than adequately treated in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 10 years).
  • Major hepatic insufficiency.
  • Active infection and diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119899

Locations
Netherlands
MMC
Veldhoven, Brabant, Netherlands
UMC ST Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
UMCVU
Amsterdam, Noord Holland, Netherlands
UMCG
Groningen, Netherlands
Sponsors and Collaborators
Radboud University
VU University Medical Center
University Medical Centre Groningen
MMC Hopsital Veldvoven (Department of Surgery)
Investigators
Principal Investigator: Wim JG Oyen, MD, Phd Radboud University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00119899     History of Changes
Other Study ID Numbers: POLEM (ZonMW DO 945-11017), (ZonMW DO 945-11017)
Study First Received: July 6, 2005
Last Updated: August 30, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Colorectal Cancer;
Liver;
Metastases;
Resection;
 Fluorodeoxyglucose;
Tomography;
Positron-Emission

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013