Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus

Adenocarcinoma Esophagus Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02991547
• Other study ID #: 1611-55
• Status: Terminated
• Start date: December 2016
• Est. completion date: August 3, 2018

Study information

• Verified date: February 2024
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma Esophagus

Intervention

Other:
• Observational

Locations

Country	Name	City	State
United States	Guthrie Corning Hospital	Corning	New York
United States	Guthrie Medical Group, PC/Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		5 years
Secondary	Overall survival		5 years
Secondary	Rate of complete remission		8 weeks after completion of neoadjuvant chemoradiotherapy
Secondary	Occurrence of local recurrence or mestastasis or both		5 years
Secondary	Adverse effect profile		5 years