Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus (SAGE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Adenocarcinoma Esophagus
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Corning, New York, United States, 14830
      • Guthrie Corning Hospital
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, PC/Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with adenocarcinoma of the esophageal and gastroesophageal junction

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	5 years

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Study Director: Joyson Poulose, MD, Guthrie Medical Group, PC/Robert Packer Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): August 3, 2018
• Study Completion (Actual): August 3, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 1611-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO