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RECRUITING
NCT05332002
PHASE2

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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

Interventions

DRUG

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