Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus
Stopped early
Conditions studied: Adenocarcinoma Esophagus
In brief
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.
Key facts
- Study ID
- NCT02991547
- Run by
- The Guthrie Clinic
- People needed
- 3
- Starts
- 2016-12-01
- Expected to finish
- 2018-08-03
- Last updated by the study team
- 2024-02-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Pregnancy
- 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
Where it is running
- Guthrie Corning Hospital — Corning, New York, United States
- Guthrie Medical Group, PC/Robert Packer Hospital — Sayre, Pennsylvania, United States
Full record on ClinicalTrials.gov
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