Clinical Research Directory
Browse clinical research sites, groups, and studies.
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Sponsor: Rutgers, The State University of New Jersey
Summary
The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.
Official title: A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2022-07-13
Completion Date
2026-08-01
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
This is a Single Arm Phase II trial of q4week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor 2 (HER2) negative gastric and esophageal cancers (GEC). The study treatment is a chemotherapy combination of either FOLFOX or FOLFIRI as below: 1. mFOLFOX6: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2: 2. FOLFIRI: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2 3. Nivolumab(Optional) The chemotherapy combination of FOLFOX and FOLFIRI is a FDA approved treatment for advanced bowel and gastric
Locations (6)
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
New Brunswick, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States