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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00828620
• Other study ID #: s51276 - ML5241
• Status: Terminated
• Phase: N/A
• First received: January 23, 2009
• Last updated: August 9, 2012
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Imaging study
PET-CT

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ Groeninge	Kortrijk
Belgium	UZLeuven	Leuven
Belgium	H Hart Roeselare Campus menen	Menen
Belgium	Stedelijk Ziekenhuis Roeselare	Roeselare
Belgium	Sint Augustinus Ziekenhuis	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET response on day 7		day 7	No
Secondary	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	No
Secondary	To define the optimal cutoff value of SUVmax and their predictive value		at day 7 and week 6	No
Secondary	To explore the test/retest reliability of PET/CT in this setting		2 weeks	No
Secondary	To assess the value of PET/CT at day 7 in predicting overall survival		up to 1 year	No
Secondary	To asses the correlations between biomarkers and PET changes after Cetuximab		up to 6 months	No