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

Alliance for Clinical Trials in Oncology35 sites in 1 country235 target enrollmentNovember 1999

Interventionsconventional surgery positron emission tomography chemotherapy radionuclide imaging fludeoxyglucose F 18 Radiotherapy

Overview

Phase: Not Applicable
Intervention: conventional surgery
Conditions: Esophageal Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Enrollment: 235
Locations: 35
Primary Endpoint: Proportion of these patients with FDG-PET findings that contraindicate surgery
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1999

End Date

January 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alliance for Clinical Trials in Oncology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must be ≥ 18 years of age.
•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).
•Patient must be deemed medically fit for surgical staging procedures and esophagectomy following the thoracic surgeon's evaluation of general medical fitness.
•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, M
•Patient must be able to tolerate FDG-PET scan (e.g., not claustrophobic and able to lie supine for 1.5 hrs).
•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.
•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.
•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.

Exclusion Criteria

•Patient has proximal esophageal cancer (less than 20 cm from incisors) potentially requiring pharyngolaryngoesophagectomy.
•Patient has unresectable lesions (stage M1b, with biopsy confirmation of distant metastatic disease; or those with unresectable locoregional invasion, T4 Nx Mx).
•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).
•Patient has had a prior FDG-PET scan for evaluation of their esophageal cancer.
•Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value \>200 mg/dL, within 12 hours of FDG-PET scan.
•Patient has received neoadjuvant chemotherapy and/or radiotherapy PRIOR to FDG-PET scan being performed.

Arms & Interventions

FDG-PET scan +/- neoadjuvant chemotherapy + 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.

Intervention: conventional surgery