Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

Cervical esophageal cancers arising 15-18 cm from the incisors.

Esophageal squamous cell carcinoma.

Patients with T4b disease according to the AJCC 8th Edition.

Definitive clinical or radiologic evidence of metastatic disease.

Trial design

Treatments tested in this trial

  • FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

1
Duke University Medical Center27710, DurhamNorth Carolina, United States

Sponsors and collaborators

Duke University

Lead sponsor