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

National Taiwan University

Status: Unknown

Conditions: Esophageal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01927978

201207067MIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

esophageal cancer, 18F-FDG PET