Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus (SAGE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02991547
Recruitment Status :
(Initial Principal Investigator no longer at institution.)
The purpose of this study is to find out more information about patients who have cancer (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated with chemotherapy and radiation but have not had surgery. The study will follow patients for 5 years to monitor for their cancer and to see how the standard medical care affects the daily life of patients.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with adenocarcinoma of the esophageal and gastroesophageal junction
Adenocarcinoma of esophagus or gastroesophageal junction (nidus of the cancer within 5 cm from the gastroesophageal junction) confirmed by biopsy with clinical stage I, II, or III. The superficial adenocarcinoma of the esophagus will be excluded.
Received no previous treatment for esophageal cancer.
Measurable or evaluable disease
ECOG performance status: 0 to 2 that is able to perform activities of daily living with minimal assistance
Adequate bone marrow function (hemoglobulin ≥8 g/dl, neutrophil ≥1.5x109/L and platelet ( ≥100x109/L)
Adequate liver function
Bilirubin normal, Meets 1 of the following criteria:
Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)
AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
AP ≤ 5 times ULN AND AST/ALT normal
Adequate kidney function (creatinine ≤1.5 UNL and creatinine clearance ≥ 60 )
Be at least 4 weeks from recent major surgical procedures.
Patients must be able to understand the nature of the study and give written informed consent
At least one measurable lesion on CT, MRI or esophageal barium exam.
Age < 18 years and >80 years
Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or hematemesis
Participating in other clinical trials
Clinically significant and uncontrolled major medical conditions including but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements
any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities