Early Metabolic Response in Locally Advanced Esophageal Cancer Undergoing Induction Chemoradiotherapy

Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma) Clinical Trial

Official title:

Early Metabolic Response Evaluation With 18-FDG PET-CT in Esophageal Cancer Treated With Neoadjuvant Chemoradiotherapy Followed by Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269970
• Other study ID #: G.0175.03
• Secondary ID: S24640
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 3, 2011
• Start date: January 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Squamous Cell
• Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)
• Esophageal Neoplasms

Intervention

Other:
• 18-FDG-PET-CT

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to study correlations between early metabolic response, late metabolic response, histopathological response and outcome.