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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
  Purpose

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 Intervention
Metastatic Colorectal Cancer
Other: Imaging study

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • PET response on day 7 [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PET-CT
Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab
Other: Imaging study
PET-CT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828620

Locations
Belgium
ZNA Middelheim
Antwerpen, Belgium
AZ Groeninge
Kortrijk, Belgium
UZLeuven
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
Investigators
Principal Investigator: Eric Van Cutsem, Prof.Dr UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00828620     History of Changes
Other Study ID Numbers: s51276 - ML5241
Study First Received: January 23, 2009
Last Updated: August 9, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on November 25, 2014