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A022102

Trial Overview

Official Title

RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Study Purpose

To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma

Diagnosis

Stage: unresectable or metastatic adenocarcinoma Tumor Site: esophagus, gastroesophageal junction, or stomach

Eligibility

18 years of age or older

No prior treatment for metastatic or unresectable adenocarcinoma of esophagus, stomach, or gastroesophageal junction

Intervention

Arm 1

mFOLFIRINOX +/- nivo

Arm 2

mFOLFOX6 +/- nivo

Patients will be randomized in this study, meaning that the treatment to either Arm 1 or Arm 2 is assigned by a computer.  Patient or physician will not be able to choose the treatment arm.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center Methodist Jennie Edmundson Hospital
Gender
Male or Female
Age
18 Years of age or older
Enrollment Status
Recruiting
Phase
Not Applicable