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SAGE: Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus

Sponsor
The Guthrie Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT02991547
Collaborator
(none)
3
Enrollment
2
Locations
20
Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational

Study Design

Study Type:
Observational
Actual Enrollment :
3 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Aug 3, 2018
Actual Study Completion Date :
Aug 3, 2018

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [5 years]

Secondary Outcome Measures

  1. Overall survival [5 years]

  2. Rate of complete remission [8 weeks after completion of neoadjuvant chemoradiotherapy]

  3. Occurrence of local recurrence or mestastasis or both [5 years]

  4. Adverse effect profile [5 years]

  5. Quality of Life [5 years]

    EORTC QLQ-C30

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guthrie Corning Hospital Corning New York United States 14830
2 Guthrie Medical Group, PC/Robert Packer Hospital Sayre Pennsylvania United States 18840

Sponsors and Collaborators

  • The Guthrie Clinic

Investigators

  • Principal Investigator: Philip Lowry, MD, Guthrie Medical Group, PC/Robert Packer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Guthrie Clinic
ClinicalTrials.gov Identifier:
NCT02991547
Other Study ID Numbers:
  • 1611-55
First Posted:
Dec 13, 2016
Last Update Posted:
Dec 13, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Adenocarcinoma

Study Results

No Results Posted as of Dec 13, 2018