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Initial Principal Investigator no longer at institution.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Rate of complete remission | 8 weeks after completion of neoadjuvant chemoradiotherapy | |
| Occurrence of local recurrence or mestastasis or both |
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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
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:
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Patients with adenocarcinoma of the esophageal and gastroesophageal junction
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| Name | Affiliation | Role |
|---|---|---|
| Joyson Poulose, MD | Guthrie Medical Group, PC/Robert Packer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guthrie Corning Hospital | Corning | New York | 14830 | United States | ||
| Guthrie Medical Group, PC/Robert Packer Hospital |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 5 years |
| Adverse effect profile | 5 years |
| Sayre |
| Pennsylvania |
| 18840 |
| United States |