NCT02991547TerminatedNot Applicable
Study on Outcomes of Active Surveillance Among Invasive Locoregional Adenocarcinoma of Esophagus and Gastroesophageal Junction (GEJ) With Complete Response After Neoadjuvant Combined Chemoradiotherapy
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- The Guthrie Clinic
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Progression free survival
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 5 years
Secondary Outcomes
- Occurrence of local recurrence or mestastasis or both(5 years)
- Adverse effect profile(5 years)
- Overall survival(5 years)
- Rate of complete remission(8 weeks after completion of neoadjuvant chemoradiotherapy)
Investigators
Study Sites (2)
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