Positron Emission Tomography in Determining Stage of Esophageal Cancer
NCT ID: NCT00004867
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
235 participants
INTERVENTIONAL
1999-11-30
2009-01-31
Brief Summary
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PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.
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Detailed Description
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Primary Objective:
To evaluate whether FDG-PET imaging can detect lesions that would preclude surgery (esophagectomy) in patients found to be surgical candidates by standard imaging procedures.
Secondary Objective:
To use the collected data to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET imaging is best able to identify.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FDG-PET scan +/- neoadjuvant chemotherapy + surgery
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.
conventional surgery
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
chemotherapy
Radiotherapy
Interventions
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conventional surgery
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
chemotherapy
Radiotherapy
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness.
4. 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.
5. Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs).
6. 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.
7. 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.
8. 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.
9. 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.
Exclusion Criteria
2. Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).
3. 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).
4. Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.
5. Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value \>200 mg/dL, within 12 hours of FDG-PET scan.
6. Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Bryan F. Meyers, MD, MPH
Role: STUDY_CHAIR
Washington University Siteman Cancer Center
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Morton Plant Hospital
Clearwater, Florida, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Cancer Center at Greater Baltimore Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee, Memphis
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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CDR0000067526
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0060
Identifier Type: -
Identifier Source: org_study_id
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