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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02385604
Date of registration: 02/03/2015
Prospective Registration: No
Primary sponsor: St. James's Hospital, Ireland
Public title: The Predictive Value of CT-PET in Esophageal Cancer
Scientific title: CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer
Date of first enrolment: January 2014
Target sample size: 250
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02385604
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Ireland
Contacts
Name:     John V Reynolds, MCh FRCS
Address: 
Telephone:
Email:
Affiliation:  Department of Surgery, St. James's Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- Locally advanced esophageal or junctional neoplasm

- Histologically confirmed adenocarcinoma or squamous cell carcinoma

- Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board

- CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study
Center

- CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection

Exclusion Criteria:

- Incomplete data, patient lost to follow-up

- Scans performed at alternate Center



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Esophageal Neoplasms
Intervention(s)
Primary Outcome(s)
Overall survival [Time Frame: Undetermined]
Disease-free survival [Time Frame: Undetermined]
Secondary Outcome(s)
Histopathologic response [Time Frame: Undetermined]
Secondary ID(s)
12/009/2011
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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