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Positron Emission Tomography in Determining Stage of Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004867
First received: March 7, 2000
Last updated: December 26, 2009
Last verified: April 2005
History of Changes
  Purpose

RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer.

PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.


Condition Intervention
Esophageal Cancer
 Procedure: conventional surgery
Procedure: positron emission tomography
Procedure: radionuclide imaging
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of fludeoxyglucose F 18 positron emission tomography imaging in detecting lesions that would preclude esophagectomy in patients with carcinoma of the thoracic esophagus or gastroesophageal junction.

OUTLINE: This is a multicenter study.

Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy or other imaging studies, are then conducted to confirm the FDG PET imaging results. Patients with no metastases identified by FDG PET imaging may undergo esophagectomy with or without neoadjuvant chemoradiotherapy within 1 month of evaluation.

Patients are followed within 6 months after surgery.

PROJECTED ACCRUAL: A total of 120-235 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma or squamous cell carcinoma of the thoracic esophagus (at least 20 cm from incisors) or gastroesophageal junction

    • Stage T1-3, N0-1, M0-1a
    • Amenable to curative surgery
    • No proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy
  • Regional lymph node involvement allowed
  • No unresectable locoregional invasion

  • No distant metastatic disease including any or all of the following:

    • Positive cytology of the pleura, pericardium, or peritoneum
    • Metastasis to the brain, bone, lung, liver, or adrenals
    • Involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophagorespiratory fistula)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No uncontrolled diabetes mellitus (fasting blood glucose greater than 200mg/dL) within 12 hours prior to PET scan (no diabetic medications within 4 hours prior to checking blood glucose level)
  • Able to fast for at least 4 hours

  • Able to tolerate PET imaging

    • Not claustrophobic
    • Able to lie supine for 1.5 hours
  • Not pregnant
  • Negative pregnancy test
  • No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanomatous skin cancer and prior malignancy at low risk of recurrence
  • Medically fit for staging procedures or esophagectomy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Neoadjuvant chemotherapy or chemoradiotherapy allowed if administered after fludeoxyglucose F 18 positron emission tomography (PET) imaging

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Chemotherapy
  • Neoadjuvant radiotherapy allowed if administered after fludeoxyglucose F 18 PET imaging

Surgery:

  • See Disease Characteristics

Other:

  • No prior fludeoxyglucose F 18 PET imaging
  • Concurrent enrollment in other clinical trials allowed except those involving fludeoxyglucose F 18 PET imaging
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004867

  Show 35 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Bryan F. Meyers, MD, MPH Washington University Siteman Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00004867     History of Changes
Other Study ID Numbers: CDR0000067526, ACOSOG-Z0060
Study First Received: March 7, 2000
Last Updated: December 26, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
 stage IV esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013