Positron Emission Tomography in Determining Stage of Esophageal Cancer
The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus
2 other identifiers
interventional
235
1 country
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 1999
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
March 7, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJanuary 24, 2017
January 1, 2017
5.7 years
March 7, 2000
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of these patients with FDG-PET findings that contraindicate surgery
Up to 1 month post-FDG-PET scan
Secondary Outcomes (1)
The proportion of false positive lesions found by FDG-PET.
Up to 6 months post-surgery
Study Arms (1)
FDG-PET scan +/- neoadjuvant chemotherapy + surgery
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patient must be ≥ 18 years of age.
- Patient must have histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (greater than or equal to 20 cm from incisors) or gastroesophageal junction. (Pathology report must be submitted).
- Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness.
- Patient's clinical staging data (clinical examination, laboratory tests, and standard radiological staging assessments) must be obtained within 60 days prior to registration and must suggest that the tumor is potentially resectable, including tumors staged T1-3, N0-1, M0.
- Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs).
- Female patient of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to FDG-PET.
- NOTE: Pregnancy test is required to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy.
- Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study related procedures.
- Patient must provide written authorization to allow the use and disclosure of their protected health information.
- NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study pre-registration.
- A cancer survivor is eligible provided that ALL of the following criteria are met and documented:
- the patient has undergone potentially curative therapy for all prior malignancies and
- there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer) and
- the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
You may not qualify if:
- Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy.
- Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).
- Patient has evidence of metastatic disease.
- NOTE: Obvious metastasis that is based on clinical evaluation includes any or all of the following: positive cytology of pleura, pericardium, or peritoneum; metastasis to brain, bone, lung, liver, or adrenals; positive biopsy or cytology of metastasis to supraclavicular lymph nodes; and involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophago-respiratory fistula).
- Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.
- Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value \>200 mg/dL, within 12 hours of FDG-PET scan.
- Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460, United States
University of South Alabama Cancer Research Institute
Mobile, Alabama, 36688, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305-5407, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Cancer Center at Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44302, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, 90027, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601-2282, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, 15243-1899, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6838, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0037, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104, United States
Related Publications (1)
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. doi: 10.1016/j.athoracsur.2008.04.043.
PMID: 18640307RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bryan F. Meyers, MD, MPH
Washington University Siteman Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2000
First Posted
January 27, 2003
Study Start
November 1, 1999
Primary Completion
July 1, 2005
Study Completion
January 1, 2009
Last Updated
January 24, 2017
Record last verified: 2017-01