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Positron Emission Tomography in Determining Stage of Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004867
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 24, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: conventional surgery Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Drug: chemotherapy Radiation: Radiotherapy Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus
Study Start Date : November 1999
Actual Primary Completion Date : July 2005
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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.

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

Primary Outcome Measures :
  1. Proportion of these patients with FDG-PET findings that contraindicate surgery [ Time Frame: Up to 1 month post-FDG-PET scan ]

Secondary Outcome Measures :
  1. The proportion of false positive lesions found by FDG-PET. [ Time Frame: Up to 6 months post-surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004867

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

Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00004867    
Other Study ID Numbers: ACOSOG-Z0060
CDR0000067526 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Alliance for Clinical Trials in Oncology:
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:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action