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Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus (SAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991547
Recruitment Status : Terminated (Initial Principal Investigator no longer at institution.)
First Posted : December 13, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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
Adenocarcinoma Esophagus Other: Observational

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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 : December 2016
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. Rate of complete remission [ Time Frame: 8 weeks after completion of neoadjuvant chemoradiotherapy ]
  3. Occurrence of local recurrence or mestastasis or both [ Time Frame: 5 years ]
  4. Adverse effect profile [ Time Frame: 5 years ]
  5. Quality of Life [ Time Frame: 5 years ]
    EORTC QLQ-C30



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with adenocarcinoma of the esophageal and gastroesophageal junction
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991547


Locations
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United States, New York
Guthrie Corning Hospital
Corning, New York, United States, 14830
United States, Pennsylvania
Guthrie Medical Group, PC/Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Philip Lowry, MD Guthrie Medical Group, PC/Robert Packer Hospital
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02991547    
Other Study ID Numbers: 1611-55
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms