Positron Emission Tomography in Determining Stage of Esophageal Cancer

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Procedure: conventional surgery; Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18; Drug: chemotherapy; Radiation: Radiotherapy

• Registration Number: NCT00004867
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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:

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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2000-03-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-07
• Study Completion: 2009-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	conventional surgery	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.
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	positron emission tomography	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.
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	radionuclide imaging	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.
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	fludeoxyglucose F 18	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.
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	chemotherapy	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.
FDG-PET scan +/- neoadjuvant chemotherapy + surgery	Radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Proportion of these patients with FDG-PET findings that contraindicate surgery	Up to 1 month post-FDG-PET scan

Secondary Outcome Measures

Name	Time	Method
The proportion of false positive lesions found by FDG-PET.	Up to 6 months post-surgery

Trial Locations

Locations (35)

Greenebaum Cancer Center at University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Cancer Center at Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University; 🇺🇸 Columbus, Ohio, United States

St. Clair Memorial Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Tri-Health Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

Westmoreland Regional Hospital; 🇺🇸 Greensburg, Pennsylvania, United States

William Beaumont Hospital - Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Tennessee, Memphis; 🇺🇸 Memphis, Tennessee, United States

Massey Cancer Center at Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Comprehensive Cancer Center at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Providence Cancer Center at Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus; 🇺🇸 Nashville, Tennessee, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

McDowell Cancer Center at Akron General Medical Center; 🇺🇸 Akron, Ohio, United States

University of South Alabama Cancer Research Institute; 🇺🇸 Mobile, Alabama, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

Stanford Cancer Center at Stanford University Medical Center; 🇺🇸 Stanford, California, United States

SUNY Upstate Medical University Hospital; 🇺🇸 Syracuse, New York, United States

Siteman Cancer Center at Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus; 🇺🇸 Seattle, Washington, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States