Neoadjuvant Chemoradiation Therapy with Oxaliplatin and Capecitabine for Patients with Surgically Resectable Gastric Cancer: A Pilot Phase II Trial with Molecular Correlates

Biopsy-proven, newly diagnosed, primary adenocarcinoma of the stomach that is amenable to curative surgical resection. Biopsy within 28 days prior to reg. No GEJ tumors. T2-4, M0 disease. EUS and laparascopy within 28 days prior to reg. Either abdominal/pelvic CT scan or PET within 28 days prior to reg. Pts with enlarged lymph nodes outside of radiation fields must have pre-operative biopsies. Must not have positive lymph nodes outside radiation fields. Measurable or non-measurable dz. Measurable assessed within 28 days prior to reg; non-measurable assessed within 42 days prior to reg. Must submit tissue for path review. Must also seek consent for submission of specimens for correlative studies. No prior therapy for this tumor. Zubrod 0-1. Within 28 days prior to reg: ANC>/=1,500/mcl; platelets >/=100,000/mcl; WBC>/=3,000/mcl; serum creatinine</=1.5xIULN; albumin>/=3 g/dl; direct serum bilirubin</=IULN. EKG within 42 days prior to reg. No ischemic heart disease. No symptoms of angina. Not undergoing active tx for coronary artery dz. No history of documented MI, coronary angioplasty, or coronary stinting. No documented DVT within 12 months prior to reg. No pre-existing peripheral neuropathy. No active pneumonia or inflammatory lung infiltrate. No significant medical co-morbid conditions that would prevent delivery of chemo, RT or surgery. No pregnant or nursing women. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been dz-free for 5 years.