Positron Emission Tomography in Determining Stage of Esophageal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 7, 2000

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 1999

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Positron Emission Tomography in Determining Stage of Esophageal Cancer

Official Title ^ICMJE

The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Carcinoma of the Thoracic Esophagus

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:

Determine the efficacy of fludeoxyglucose F 18 positron emission tomography imaging in detecting lesions that would preclude esophagectomy in patients with carcinoma of the thoracic esophagus or gastroesophageal junction.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 120-235 patients will be accrued for this study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Esophageal Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically proven adenocarcinoma or squamous cell carcinoma of the thoracic esophagus (at least 20 cm from incisors) or gastroesophageal junction
- Stage T1-3, N0-1, M0-1a
- Amenable to curative surgery
- No proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy
Regional lymph node involvement allowed
No unresectable locoregional invasion
No distant metastatic disease including any or all of the following:
- Positive cytology of the pleura, pericardium, or peritoneum
- Metastasis to the brain, bone, lung, liver, or adrenals
- Involvement of the tracheobronchial tree (positive bronchoscopic biopsy or overt esophagorespiratory fistula)

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No uncontrolled diabetes mellitus (fasting blood glucose greater than 200mg/dL) within 12 hours prior to PET scan (no diabetic medications within 4 hours prior to checking blood glucose level)
Able to fast for at least 4 hours
Able to tolerate PET imaging
- Not claustrophobic
- Able to lie supine for 1.5 hours
Not pregnant
Negative pregnancy test
No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanomatous skin cancer and prior malignancy at low risk of recurrence
Medically fit for staging procedures or esophagectomy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Neoadjuvant chemotherapy or chemoradiotherapy allowed if administered after fludeoxyglucose F 18 positron emission tomography (PET) imaging

Endocrine therapy:

Not specified

Radiotherapy:

See Chemotherapy
Neoadjuvant radiotherapy allowed if administered after fludeoxyglucose F 18 PET imaging

Surgery:

See Disease Characteristics

Other:

No prior fludeoxyglucose F 18 PET imaging
Concurrent enrollment in other clinical trials allowed except those involving fludeoxyglucose F 18 PET imaging

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004867

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067526, ACOSOG-Z0060

Study Sponsor ^ICMJE

American College of Surgeons

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Bryan F. Meyers, MD, MPH

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP