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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00828620
First received: January 23, 2009
Last updated: August 9, 2012
Last verified: June 2012

January 23, 2009
August 9, 2012
January 2009
October 2011   (final data collection date for primary outcome measure)
PET response on day 7 [ Time Frame: day 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00828620 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To define the optimal cutoff value of SUVmax and their predictive value [ Time Frame: at day 7 and week 6 ] [ Designated as safety issue: No ]
  • To explore the test/retest reliability of PET/CT in this setting [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • To assess the value of PET/CT at day 7 in predicting overall survival [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • To asses the correlations between biomarkers and PET changes after Cetuximab [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Metastatic Colorectal Cancer
Other: Imaging study
PET-CT
PET-CT
Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab
Intervention: Other: Imaging study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
June 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00828620
s51276 - ML5241
Yes
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Eric Van Cutsem, Prof.Dr UZ Leuven
Universitaire Ziekenhuizen Leuven
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP