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Positron Emission Tomography in Determining Stage of Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
chemotherapy
Radiotherapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Mobile Infirmary Medical Center
  • University of South Alabama Cancer Research Institute
  • Jonsson Comprehensive Cancer Center at UCLA
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • UCSF Comprehensive Cancer Center
  • Stanford Cancer Center at Stanford University Medical Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Morton Plant Hospital
  • Indiana University Cancer Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Cancer Center at Greater Baltimore Medical Center
  • Massachusetts General Hospital Cancer Center
  • William Beaumont Hospital - Royal Oak
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Memorial Sloan-Kettering Cancer Center
  • SUNY Upstate Medical University Hospital
  • Duke Comprehensive Cancer Center
  • McDowell Cancer Center at Akron General Medical Center
  • Bethesda North Hospital
  • Tri-Health Good Samaritan Hospital
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Providence Cancer Center at Providence Portland Medical Center
  • Westmoreland Regional Hospital
  • Allegheny General Hospital
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • St. Clair Memorial Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • University of Tennessee, Memphis
  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Baylor University Medical Center
  • LDS Hospital
  • Massey Cancer Center at Virginia Commonwealth University
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG-PET scan +/- neoadjuvant chemotherapy + surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of these patients with FDG-PET findings that contraindicate surgery

Secondary Outcome Measures

The proportion of false positive lesions found by FDG-PET.

Full Information

First Posted
March 7, 2000
Last Updated
January 20, 2017
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004867
Brief Title
Positron Emission Tomography in Determining Stage of Esophageal Cancer
Official Title
The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG-PET scan +/- neoadjuvant chemotherapy + surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Procedure
Intervention Name(s)
radionuclide imaging
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Proportion of these patients with FDG-PET findings that contraindicate surgery
Time Frame
Up to 1 month post-FDG-PET scan
Secondary Outcome Measure Information:
Title
The proportion of false positive lesions found by FDG-PET.
Time Frame
Up to 6 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan F. Meyers, MD, MPH
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36640-0460
Country
United States
Facility Name
University of South Alabama Cancer Research Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5407
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Cancer Center at Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Tri-Health Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
90027
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Westmoreland Regional Hospital
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601-2282
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
St. Clair Memorial Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243-1899
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Tennessee, Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18640307
Citation
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.
Results Reference
result

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Positron Emission Tomography in Determining Stage of Esophageal Cancer

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