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

The Guthrie Clinic

Status: Terminated

Conditions: Adenocarcinoma Esophagus

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT02991547

1611-55

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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