A Single-arm Study of Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
Duke University
Summary
The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject must be able to provide study specific informed consent prior to study entry * Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II); * Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition; * Complete history and physical examination within 21 days of signing consent; * Staging whole-body FDG-PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography) scan with or without contrast (preferred) or chest/abdominal…
Interventions
- DrugFOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Modified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)
Location
- Duke University Medical CenterDurham, North Carolina