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CompletedNCT01269970Updated Jan 4, 2011

Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

An observational study in Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma), sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2011-01-04.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Sex
All
01

Study 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.

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Conditions studied

  • Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

Browse Esophageal Neoplasms studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective

Groups and cohorts

  • locally advanced esophageal carcinoma (cT2-3N0/+)

    Other: 18-FDG-PET-CT

Interventions

  • Other18-FDG-PET-CT
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What researchers measure

Primary outcomes

  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 outcomes

  1. to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.

07

Study locations

1 site
  • UZLeuven
    Leuven, Vlaams-Brabant 3000, Belgium
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01269970
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
First posted
Jan 4, 2011
Start date
Jan 2004
Primary completion
Jul 2008
Completion
Dec 2009
Last update
Jan 4, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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