Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Bryan F. Meyers, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067526

NCT ID:

NCT00004867

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
LDS HospitalSalt Lake City, Utah  84143
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of South Alabama Cancer Research InstituteMobile, Alabama  36604
William Beaumont Hospital - Royal OakRoyal Oak, Michigan  48073-6769
University of Tennessee, MemphisMemphis, Tennessee  38163
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Baylor University Medical CenterDallas, Texas  75246
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Morton Plant HospitalClearwater, Florida  33756
Tri-Health Good Samaritan HospitalCincinnati, Ohio  45220
Westmoreland Regional HospitalGreensburg, Pennsylvania  15601-2282
St. Clair Memorial HospitalPittsburgh, Pennsylvania  15243-1899
Bethesda North HospitalCincinnati, Ohio  45242
Cancer Center at Greater Baltimore Medical CenterBaltimore, Maryland  21204