Positron Emission Tomography in Determining Stage of Esophageal Cancer

Completed · Not applicable

Conditions studied: Esophageal Cancer

In brief

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.

Key facts

Study ID: NCT00004867
Run by: Alliance for Clinical Trials in Oncology
People needed: 235
Starts: 1999-11-01
Expected to finish: 2009-01-01
Last updated by the study team: 2017-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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, M0.
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.
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.

You may not qualify if…

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.

Where it is running

Comprehensive Cancer Center at University of Alabama at Birmingham — Birmingham, Alabama, United States
Mobile Infirmary Medical Center — Mobile, Alabama, United States
University of South Alabama Cancer Research Institute — Mobile, Alabama, United States
Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center — Orange, California, United States
UCSF Comprehensive Cancer Center — San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center — Stanford, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora, Colorado, United States
Morton Plant Hospital — Clearwater, Florida, United States
Indiana University Cancer Center — Indianapolis, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
Cancer Center at Greater Baltimore Medical Center — Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital — St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
SUNY Upstate Medical University Hospital — Syracuse, New York, United States
Duke Comprehensive Cancer Center — Durham, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center — Akron, Ohio, United States
Bethesda North Hospital — Cincinnati, Ohio, United States
Tri-Health Good Samaritan Hospital — Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University — Columbus, Ohio, United States
Providence Cancer Center at Providence Portland Medical Center — Portland, Oregon, United States
Westmoreland Regional Hospital — Greensburg, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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