Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus

NCT02991547 | Terminated

• 1 other identifier: 1611-55
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adenocarcinoma Esophagus

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  5 years

Secondary Outcomes (4)

• 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

Interventions

Observational OTHER

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adenocarcinoma of the esophageal and gastroesophageal junction

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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (2)

Guthrie Corning Hospital

Corning, New York, 14830, United States

Location

Guthrie Medical Group, PC/Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Joyson Poulose, MD

  Guthrie Medical Group, PC/Robert Packer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)