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| 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 |
| 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 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma or squamous cell carcinoma of the thoracic esophagus (at least 20 cm from incisors) or gastroesophageal junction
No distant metastatic disease including any or all of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Able to tolerate PET imaging
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 35 Study Locations |
| American College of Surgeons |
| National Cancer Institute (NCI) |
| 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 
  |
| 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 |
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