RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA
This study compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
• HER2 negative unresectable or metastatic adenocarcinoma of esophagus, gastroesophageal junction, or stomach
• have not received any prior treatment for this occurrence
• prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year ago
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• untreated, symptomatic brain metastasis
• allogeneic tissue/organ transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Fluorouracil, Drug: Irinotecan, Drug: Leucovorin Calcium, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Drug: Oxaliplatin, Other: Questionnaire Administration
Cancer
Esophageal cancer, Gastric cancer