RecruitingPhase 2NCT05332002

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)


Sponsor

Rutgers, The State University of New Jersey

Enrollment

38 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SAGE) is testing whether a modified, more intense chemotherapy regimen called sFOLFOXIRI — and possibly adding an immunotherapy drug — can improve outcomes for patients with advanced stomach or esophageal cancer. **You may be eligible if...** - You are 18 or older with confirmed metastatic or unresectable stomach, esophageal, or gastroesophageal junction adenocarcinoma - Your cancer is HER2-negative - You have not received prior chemotherapy for this cancer in the metastatic setting - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - You have untreated brain metastases - You have significant nerve damage (peripheral neuropathy grade 2 or worse) - You have an active autoimmune disease requiring immunosuppression (if receiving immunotherapy) - You have had a serious infection or recent major surgery - You are allergic to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFour 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

View Full Details on ClinicalTrials.gov

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NCT05332002


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