Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project

August 9, 2012 updated by: Universitaire Ziekenhuizen KU Leuven

Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer

Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Kortrijk, Belgium
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZLeuven
      • Menen, Belgium
        • H Hart Roeselare Campus menen
      • Roeselare, Belgium
        • Stedelijk Ziekenhuis Roeselare
      • Wilrijk, Belgium
        • Sint Augustinus Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose < 200mg/dl

Description

Inclusion Criteria:

  • Histologically or cytologically proven colorectal cancer
  • Unresectable stage IV disease
  • K-Ras wild type tumour
  • Patients scheduled to undergo chemotherapy with irinotecan and cetuximab

Exclusion Criteria:

  • Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
  • Poorly controlled diabetes
  • Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
  • Symptomatic brain metastases
  • Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PET-CT
Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab
Other: Imaging study
PET-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PET response on day 7
Time Frame: day 7
day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6
Time Frame: week 6
week 6
To define the optimal cutoff value of SUVmax and their predictive value
Time Frame: at day 7 and week 6
at day 7 and week 6
To explore the test/retest reliability of PET/CT in this setting
Time Frame: 2 weeks
2 weeks
To assess the value of PET/CT at day 7 in predicting overall survival
Time Frame: up to 1 year
up to 1 year
To asses the correlations between biomarkers and PET changes after Cetuximab
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Eric Van Cutsem, Prof.Dr, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s51276 - ML5241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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