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Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

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ClinicalTrials.gov Identifier: NCT01269970
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
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Study Description
Brief Summary:
Early metabolic response evaluation may predict clinical and histopathological response after neoadjuvant chemotherapy. Its value in neoadjuvant chemoradiotherapy (CRT) is unknown. Our aim was to assess the value of early metabolic response after one cycle of chemotherapy using 18-FDG-PET-CT to predict pathological response and outcome in cT2-4 N0/+ esophageal cancer treated by neoadjuvant CRT and esophagectomy.

Condition or disease Intervention/treatment
Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma) Other: 18-FDG-PET-CT

Study Design

Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Metabolic Response Evaluation With 18-FDG PET-CT in Esophageal Cancer Treated With Neoadjuvant Chemoradiotherapy Followed by Esophagectomy
Study Start Date : January 2004
Primary Completion Date : July 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
locally advanced esophageal carcinoma (cT2-3N0/+) Other: 18-FDG-PET-CT

Outcome Measures

Primary Outcome Measures :
  1. early metabolic response to predict pathological response and outcome
    assess the value of early metabolic response with 18-FDG-PET-CT (i.e. a decrease of ≥ 35% of SUVmean) after a single cycle of chemotherapy followed by neoadjuvant CRT and esophagectomy as a tool to predict pathological response and outcome in patients with cT2-4N0/+ carcinoma of the esophagus and GE-junction (GEJ).

Secondary Outcome Measures :
  1. to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
locally advanced esophageal cancer (cT2-4 N0/+) of the esophagus (n=42) and GEJ (n=13)

Inclusion Criteria:

  • locally advanced esophageal cancer (cT2-4 N0/+)

Exclusion Criteria:

  • PET-CT not performed at UZLeuven
  • Other tumor types
  • Distant metastases (organ)
Contacts and Locations

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): NCT01269970

Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information

ClinicalTrials.gov Identifier: NCT01269970     History of Changes
Other Study ID Numbers: G.0175.03
S24640 ( Registry Identifier: clinical trial center UZLeuven )
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action