Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01269970
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention
Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
Other: 18-FDG-PET-CT

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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

Study Start Date: January 2004
Study Completion Date: December 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
locally advanced esophageal carcinoma (cT2-3N0/+) Other: 18-FDG-PET-CT

  Eligibility

Genders Eligible for Study:   Both
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)

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269970

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

No publications provided

ClinicalTrials.gov Identifier: NCT01269970     History of Changes
Other Study ID Numbers: G.0175.03, S24640
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 21, 2014