NCT01269970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

4.5 years

First QC Date

January 3, 2011

Last Update Submit

January 3, 2011

Conditions

Esophageal Carcinoma (Squamous Cell Carcinoma - Adenocarcinoma)

Outcome Measures

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.

Study Arms (1)

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

Other: 18-FDG-PET-CT

Interventions

18-FDG-PET-CTOTHER
locally advanced esophageal carcinoma (cT2-3N0/+)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

locally advanced esophageal cancer (cT2-4 N0/+) of the esophagus (n=42) and GEJ (n=13)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

January 1, 2004

Primary Completion

July 1, 2008

Study Completion

December 1, 2009

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations

BE(1)