Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal cancer, 18F-FDG PET, staging, therapy planning, therapy response monitoring, prognosis
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.

Purpose:

1. The incremental staging information by using 18F-FDG PET

2. The impact of the PET results on the patients' subsequent therapy planning

3. To compare treatment response using RECIST criteria and FDG PET results.
Detailed Description
Background: Esophageal cancer is one of the leading malignancies in Taiwan. Accuracy tumor staging can direct to appropriate therapy planning and provide prognostic implications. Positron emission tomography (PET) with [18F]-fluoro-2-deoxy-D-glucose (FDG) has been shown to have better N staging and prognostic stratification abilities than conventional imaging modalities, such as endoscopic ultrasonography (EUS) and CT.

Purpose: This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.

Method: Patients with pathological proven esophageal cancer, age 20-90 year-old, will be included in this study. Each patient will receive a baseline PET study. For those patients who received pre-operative CCRT, another PET will be performed 1-4 weeks after completion of CCRT.

Primary outcome: 1. The incremental staging information by using 18F-FDG PET 2. The impact of the PET results on the patients' subsequent therapy planning 3. To compare treatment response using RECIST criteria and FDG PET results.

Secondary outcome: To correlate the PET response rate and the patients' disease free survival and overall survival.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age:20-90 years old

2. Histological proved esophageal cancer

3. ECOG performance status 0-2

4. written informed consent signed

Exclusion Criteria:

1. prior chemotherapy or treatment for other systemic anti-cancer agent(s)

2. pregnant or intend to be pregnant

3. other malignancies known

4. other concurrent cancer treatment
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Yen Ruoh Fang, M.D., Ph.D. - 886-2-23123456 - rfyen@ntu.edu.tw
Start Date
October 2012
Completion Date
August 2014
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page