Clinical trial NCT00828620: Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project
Official title: Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: PET response on day 7
timeFrame: day 7
Secondary outcomes:
measure: 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
timeFrame: week 6
measure: To define the optimal cutoff value of SUVmax and their predictive value
timeFrame: at day 7 and week 6
measure: To explore the test/retest reliability of PET/CT in this setting
timeFrame: 2 weeks
measure: To assess the value of PET/CT at day 7 in predicting overall survival
timeFrame: up to 1 year
measure: To asses the correlations between biomarkers and PET changes after Cetuximab
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZLeuven
city: Menen
country: Belgium
facility: H Hart Roeselare Campus menen
city: Roeselare
country: Belgium
facility: Stedelijk Ziekenhuis Roeselare
city: Wilrijk
country: Belgium
facility: Sint Augustinus Ziekenhuis
Study officials:
affiliation: UZ Leuven
name: Eric Van Cutsem, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References: