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

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ClinicalTrials.gov Identifier: NCT00828620
Recruitment Status : Terminated (Lack of recruitment)
First Posted : January 26, 2009
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Other: Imaging study

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer
Study Start Date : January 2009
Primary Completion Date : October 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. PET response on day 7 [ Time Frame: day 7 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To define the optimal cutoff value of SUVmax and their predictive value [ Time Frame: at day 7 and week 6 ]
  3. To explore the test/retest reliability of PET/CT in this setting [ Time Frame: 2 weeks ]
  4. To assess the value of PET/CT at day 7 in predicting overall survival [ Time Frame: up to 1 year ]
  5. To asses the correlations between biomarkers and PET changes after Cetuximab [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828620

ZNA Middelheim
Antwerpen, Belgium
AZ Groeninge
Kortrijk, Belgium
Leuven, Belgium, 3000
H Hart Roeselare Campus menen
Menen, Belgium
Stedelijk Ziekenhuis Roeselare
Roeselare, Belgium
Sint Augustinus Ziekenhuis
Wilrijk, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Eric Van Cutsem, Prof.Dr UZ Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00828620     History of Changes
Other Study ID Numbers: s51276 - ML5241
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents