NCT01927978

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. 1.The incremental staging information by using 18F-FDG PET
  2. 2.The impact of the PET results on the patients' subsequent therapy planning
  3. 3.To compare treatment response using RECIST criteria and FDG PET results.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

August 15, 2013

Last Update Submit

April 13, 2014

Conditions

Esophageal Cancer

Keywords

Esophageal cancer18F-FDG PETstagingtherapy planningtherapy response monitoringprognosis

Outcome Measures

Primary Outcomes (1)

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

    2 hours

Study Arms (1)

esophageal cancer, 18F-FDG PET

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Histological proved esophageal cancer

You may qualify if:

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

You may not qualify if:

  • prior chemotherapy or treatment for other systemic anti-cancer agent(s)
  • pregnant or intend to be pregnant
  • other malignancies known
  • other concurrent cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (6)

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

    PMID: 14657432BACKGROUND

  • 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.

    PMID: 20512949BACKGROUND

  • 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.

    PMID: 18931839BACKGROUND

  • 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.

    PMID: 21595776BACKGROUND

  • 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.

    PMID: 22582047BACKGROUND

  • 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.

    PMID: 22582049BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Yen Ruoh Fang, M.D.,Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

886-2-23123456rfyen@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 23, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

TW(1)