Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus

Study Overview
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Brief Summary
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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.

Official Title
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Study on Outcomes of Active Surveillance Among Invasive Locoregional Adenocarcinoma of Esophagus and Gastroesophageal Junction (GEJ) With Complete Response After Neoadjuvant Combined Chemoradiotherapy

Conditions
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Adenocarcinoma Esophagus

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 
| Rate of complete remission |  | 8 weeks after completion of neoadjuvant chemoradiotherapy | 
| Occurrence of local recurrence or mestastasis or both |  | 5 years | 
| Adverse effect profile |  | 5 years | 
| Quality of Life | EORTC QLQ-C30 | 5 years |