Positron Emission Tomography in Determining Stage of Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004867
• Other study ID #: ACOSOG-Z0060
• Secondary ID: CDR0000067526
• Status: Completed
• Phase: N/A
• First received: March 7, 2000
• Last updated: January 20, 2017
• Start date: November 1999
• Est. completion date: January 2009

Study information

• Verified date: January 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 2009
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• conventional surgery

• positron emission tomography

• radionuclide imaging

Radiation:
• fludeoxyglucose F 18

Drug:
• chemotherapy

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Cancer Center at Greater Baltimore Medical Center	Baltimore	Maryland
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	University of Tennessee, Memphis	Memphis	Tennessee
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	University of South Alabama Cancer Research Institute	Mobile	Alabama
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	St. Clair Memorial Hospital	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	LDS Hospital	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California
United States	SUNY Upstate Medical University Hospital	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of these patients with FDG-PET findings that contraindicate surgery		Up to 1 month post-FDG-PET scan
Secondary	The proportion of false positive lesions found by FDG-PET.		Up to 6 months post-surgery