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

The Guthrie Clinic2 sites in 1 country3 target enrollmentDecember 2016

ConditionsAdenocarcinoma Esophagus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adenocarcinoma Esophagus
Sponsor: The Guthrie Clinic
Enrollment: 3
Locations: 2
Primary Endpoint: Progression free survival
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

August 3, 2018

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

The Guthrie Clinic

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Progression free survival

Time Frame: 5 years

Secondary Outcomes

Occurrence of local recurrence or mestastasis or both(5 years)
Adverse effect profile(5 years)
Overall survival(5 years)
Rate of complete remission(8 weeks after completion of neoadjuvant chemoradiotherapy)