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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01927978
• Other study ID #: 201207067MIC
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2013
• Last updated: April 13, 2014
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: Yen Ruoh Fang, M.D.,Ph.D.
• Phone: 886-2-23123456
• Email: rfyen[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Barber TW, Duong CP, Leong T, Bressel M, Drummond EG, Hicks RJ. 18F-FDG PET/CT has a high impact on patient management and provides powerful prognostic stratification in the primary staging of esophageal cancer: a prospective study with mature survival data. J Nucl Med. 2012 Jun;53(6):864-71. doi: 10.2967/jnumed.111.101568. Epub 2012 May 11. — View Citation

Chatterton BE, Ho Shon I, Baldey A, Lenzo N, Patrikeos A, Kelley B, Wong D, Ramshaw JE, Scott AM. Positron emission tomography changes management and prognostic stratification in patients with oesophageal cancer: results of a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2009 Mar;36(3):354-61. doi: 10.1007/s00259-008-0959-y. Epub 2008 Oct 18. — View Citation

Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med. 2003 Dec 4;349(23):2241-52. Review. — View Citation

Ng T, Vezeridis MP. Advances in the surgical treatment of esophageal cancer. J Surg Oncol. 2010 Jun 15;101(8):725-9. doi: 10.1002/jso.21566. Review. — View Citation

Yanagawa M, Tatsumi M, Miyata H, Morii E, Tomiyama N, Watabe T, Isohashi K, Kato H, Shimosegawa E, Yamasaki M, Mori M, Doki Y, Hatazawa J. Evaluation of response to neoadjuvant chemotherapy for esophageal cancer: PET response criteria in solid tumors versus response evaluation criteria in solid tumors. J Nucl Med. 2012 Jun;53(6):872-80. doi: 10.2967/jnumed.111.098699. Epub 2012 May 11. — View Citation

Yen TJ, Chung CS, Wu YW, Yen RF, Cheng MF, Lee JM, Hsu CH, Chang YL, Wang HP. Comparative study between endoscopic ultrasonography and positron emission tomography-computed tomography in staging patients with esophageal squamous cell carcinoma. Dis Esophagus. 2012 Jan;25(1):40-7. doi: 10.1111/j.1442-2050.2011.01204.x. Epub 2011 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.		2 hours	No