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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02991547
Other study ID # 1611-55
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Recruiting NCT05067842 - Circulating Tumor DNA (ctDNA) in Locally Advanced Esophageal and Gastroesophageal (GE) Junction Adenocarcinoma
Completed NCT02971956 - Pembrolizumab in Refractory Advanced Esophageal Cancer Phase 2
Recruiting NCT04818476 - Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus
Recruiting NCT04028167 - Induction FLOT With CROSS CRT for Esophageal Cancer Phase 2