Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer

• Conditions: Esophageal Cancer

• Registration Number: NCT01927978
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-13
• Last Update Posted: 2014-04-15
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age：20-90 years old
2. Histological proved esophageal cancer
3. ECOG performance status 0-2
4. written informed consent signed

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.	2 hours

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan