Conditions: Esophageal Adenocarcinoma
Keywords: Esophageal Esophagus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable.

Detailed description:
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.

Arms:
arm 1: Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab

Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Cetuximab
Intervention descriptions: intervention 1: Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4 intervention 2: Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4 intervention 3: Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

Protocol document: