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Esophageal CancerNCT00004867

Positron Emission Tomography in Determining Stage of Esophageal Cancer

A study testing conventional surgery, positron emission tomography and radionuclide imaging in people with Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
conventional surgery, positron emission tomography and radionuclide imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
35 sitesUnited States
Study dates
Nov 1999to Jan 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44302

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Cancer Center at Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 90027

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Westmoreland Regional Hospital

    Greensburg, Pennsylvania, 15601-2282

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • University of Tennessee, Memphis

    Memphis, Tennessee, 38163

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36640-0460

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36688

  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

    Nashville, Tennessee, 37212

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6838

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • St. Clair Memorial Hospital

    Pittsburgh, Pennsylvania, 15243-1899

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0037

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305-5407

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
conventional surgery, positron emission tomography, radionuclide imaging, fludeoxyglucose F 18, chemotherapy
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
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00004867
Study groupRoleWhat they receive
FDG-PET scan +/- neoadjuvant chemotherapy + surgeryExperimentalPatients 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.
Receives: Procedure: conventional surgery; Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18; Drug: chemotherapy; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 1 month post-FDG-PET scan

Secondary outcomes (1)

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

    Measured: Up to 6 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1999
  3. Primary completionJul 2005
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004867
Sponsor's protocol ID
ACOSOG-Z0060
Other IDs
CDR0000067526
Status last verified
Jan 2017
First submitted
7 Mar 2000
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 18640307

Questions about this trial

What is this clinical trial studying?

A study testing conventional surgery, positron emission tomography and radionuclide imaging in people with Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of these patients with FDG-PET findings that contraindicate surgery (time frame: Up to 1 month post-FDG-PET scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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