Positron Emission Tomography in Determining Stage of Esophageal Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	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	Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Nuclear Scans Surgery

Drug Information available for: Fluorodeoxyglucose F18

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

Hide Study Locations

Locations

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36688
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5407
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Cancer Center at Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44302
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States, 90027
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States, 15243-1899
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States, 15601-2282
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee, Memphis
Memphis, Tennessee, United States, 38163
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104

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

Additional Information:

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

Publications:

Veeramachaneni NK, Zoole JB, Decker PA, Putnam JB Jr, Meyers BF; American College of Surgeons Oncology Group Z0060 Trial. Lymph node analysis in esophageal resection: American College of Surgeons Oncology Group Z0060 trial. Ann Thorac Surg. 2008 Aug;86(2):418-21; discussion 421.

Study ID Numbers:	CDR0000067526, ACOSOG-Z0060
Study First Received:	March 7, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004867 History of Changes
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:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on November 27, 2009