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

NCT ID: NCT01927978

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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esophageal cancer, 18F-FDG PET

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yen Ruoh Fang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen Ruoh Fang, M.D.,Ph.D.

Role: CONTACT

886-2-23123456 ext. 65581

Facility Contacts

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Yen Ruoh Fang, M.D., Ph.D.

Role: primary

886-2-23123456 ext. 65581

References

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Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med. 2003 Dec 4;349(23):2241-52. doi: 10.1056/NEJMra035010. No abstract available.

Reference Type BACKGROUND
PMID: 14657432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20512949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18931839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21595776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22582047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22582049 (View on PubMed)

Other Identifiers

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201207067MIC

Identifier Type: -

Identifier Source: org_study_id

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