Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

Completed

• Conditions: Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
• Interventions: Other: 18-FDG-PET-CT

• Registration Number: NCT01269970
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2008-07
• Study Completion: 2009-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Last Update Submitted: 2011-01-03
• Study First Posted: 2011-01-04
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
locally advanced esophageal carcinoma (cT2-3N0/+)	18-FDG-PET-CT	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium