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Positron Emission Tomography in Determining Stage of Esophageal Cancer

This study has been completed.

Sponsors and Collaborators: American College of Surgeons
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004867
  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
Drug: fludeoxyglucose F 18
Procedure: conventional surgery
Procedure: positron emission tomography
Procedure: radionuclide imaging

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Nuclear Scans   

Drug Information available for:   Fluorodeoxyglucose F18   

U.S. FDA Resources

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

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

Study Start Date:   November 1999
Primary Completion Date:   April 2005 (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  Show 35 Study Locations

Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)

Investigators
Study Chair:     Bryan F. Meyers, MD, MPH     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
  More Information


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

Study ID Numbers:   CDR0000067526, ACOSOG-Z0060
First Received:   March 7, 2000
Last Updated:   August 29, 2008
ClinicalTrials.gov Identifier:   NCT00004867
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

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Carcinoma
Epidermoid carcinoma
Digestive System Diseases
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




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