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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Drug: chemotherapy; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: radionuclide imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient must be ≥ 18 years of age.
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:

1. Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Radiation: Radiotherapy; Drug: chemotherapy; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: radionuclide imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of these patients with FDG-PET findings that contraindicate surgery	Up to 1 month post-FDG-PET scan

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of false positive lesions found by FDG-PET.	Up to 6 months post-surgery

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Bryan F. Meyers, MD, MPH, Washington University Siteman Cancer Center

Publications and helpful links

General 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. doi: 10.1016/j.athoracsur.2008.04.043.

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 7, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: stage II esophageal cancer; stage III esophageal cancer; squamous cell carcinoma of the esophagus; adenocarcinoma of the esophagus; stage IV esophageal cancer; stage I esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: ACOSOG-Z0060; CDR0000067526 (Registry Identifier: NCI Physician Data Query)