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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004867 |
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 |
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Esophageal Cancer |
Drug: fludeoxyglucose F 18 Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging |
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.
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:
Study Chair: | Bryan F. Meyers, MD, MPH | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000067526, ACOSOG-Z0060 |
Study First Received: | March 7, 2000 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00004867 |
Health Authority: | United States: Federal Government |
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 |
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 |
Neoplasms Neoplasms by Site |