Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Positron Emission Tomography in Determining Stage of Esophageal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Treatment	Completed	18 and over	NCI	ACOSOG-Z0060 NCT00004867

Objectives

1. 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.

Entry 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)

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

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

Expected Enrollment

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

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.

Veeramachaneni NK, Zoole JB, Decker PA, et al.: Lymph node analysis in esophageal resection: American College of Surgeons Oncology Group Z0060 trial. Ann Thorac Surg 86 (2): 418-21; discussion 421, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Bryan Meyers, MD, MPH, Protocol chair		Ph: 314-362-8598; 800-600-3606

Registry Information
Official Title		The Utility of Positron Emission Tomography (PET) in Staging of Patients with Potentially Operable Carcinoma of the Thoracic Esophagus
Trial Start Date		1999-11-22
Trial Completion Date		2009-01-16
Registered in ClinicalTrials.gov		NCT00004867
Date Submitted to PDQ		2000-01-05
Information Last Verified		2005-04-26
NCI Grant/Contract Number		CA76001