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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01927978

Enrollment

Registered

2013-08-23

Start date

2012-10-31

Completion date

2014-08-31

Last updated

2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal cancer, 18F-FDG PET, staging, therapy planning, therapy response monitoring, prognosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

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

Countries

Taiwan

Contacts

Primary ContactYen Ruoh Fang, M.D.,Ph.D.

rfyen@ntu.edu.tw886-2-23123456

Outcome results