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

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: Imaging study

• Registration Number: NCT00828620
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2011-10
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET-CT	Imaging study	Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab

Primary Outcome Measures

Name	Time	Method
PET response on day 7	day 7

Secondary Outcome Measures

Name	Time	Method
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	week 6
To define the optimal cutoff value of SUVmax and their predictive value	at day 7 and week 6
To explore the test/retest reliability of PET/CT in this setting	2 weeks
To assess the value of PET/CT at day 7 in predicting overall survival	up to 1 year
To asses the correlations between biomarkers and PET changes after Cetuximab	up to 6 months

Trial Locations

Locations (6)

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

H Hart Roeselare Campus menen; 🇧🇪 Menen, Belgium

Stedelijk Ziekenhuis Roeselare; 🇧🇪 Roeselare, Belgium

UZLeuven; 🇧🇪 Leuven, Belgium

Sint Augustinus Ziekenhuis; 🇧🇪 Wilrijk, Belgium