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

NCT00119899 | Completed Phase 3

• 2 other identifiers: POLEM (ZonMW DO 945-11017)(ZonMW DO 945-11017)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Colorectal Liver Metastases; Colorectal Cancer; Neoplasm Metastasis

Keywords

Colorectal Cancer;; Liver;; Metastases;; Resection;; Fluorodeoxyglucose;; Tomography;; Positron-Emission

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival (9 months)

• Economic evaluation (9 months)

Secondary Outcomes (4)

• Disease Free Survival

• Overall Survival

• Change in Clinical Management

• Economic evaluation

Interventions

FDG-PET scan PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Amsterdam UMC, location VUmc: collaborator
• University Medical Center Groningen: collaborator
• MMC Hopsital Veldvoven (Department of Surgery): collaborator

Study Sites (4)

UMC ST Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MMC

Veldhoven, North Brabant, Netherlands

Location

UMCVU

Amsterdam, North Holland, Netherlands

Location

UMCG

Groningen, Provincie Groningen, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wim JG Oyen, MD, Phd

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 14, 2005
• Study Start: March 1, 2002
• Study Completion: June 1, 2005
• Last Updated: August 31, 2005

Record last verified: 2005-08

Locations

NL (4)