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The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus

18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus


- 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.

Inclusion Criteria


- 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)



- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy:

- Not specified


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

Endocrine therapy:

- Not specified


- See Chemotherapy

- Neoadjuvant radiotherapy allowed if administered after fludeoxyglucose F 18 PET


- See Disease Characteristics


- No prior fludeoxyglucose F 18 PET imaging

- Concurrent enrollment in other clinical trials allowed except those involving
fludeoxyglucose F 18 PET imaging

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Bryan F. Meyers, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms



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Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
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Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
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Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
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William Beaumont Hospital - Royal Oak Royal Oak, Michigan  48073-6769
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Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
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