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Positron Emission Tomography in Determining Stage of Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00004867
First received: March 7, 2000
Last updated: August 2, 2016
Last verified: August 2016
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Proportion of these patients with FDG-PET findings that contraindicate surgery [ Time Frame: Up to 1 month post-FDG-PET scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of false positive lesions found by FDG-PET. [ Time Frame: Up to 6 months post-surgery ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: November 1999
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004867

  Show 35 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Bryan F. Meyers, MD, MPH Washington University Siteman Cancer Center
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00004867     History of Changes
Other Study ID Numbers: ACOSOG-Z0060  CDR0000067526 
Study First Received: March 7, 2000
Last Updated: August 2, 2016
Health Authority: United States: Federal Government

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:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016