sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

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.

Trial Details

NCT ID
NCT05332002
Phase
PHASE2
Sponsor
Rutgers, The State University of New Jersey
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
Locations (sample)
  • Hamilton, New Jersey, United States|40.20706,-74.08125
  • Lakewood, New Jersey, United States|40.09789,-74.21764
  • Long Branch, New Jersey, United States|40.30428,-73.99236
  • New Brunswick, New Jersey, United States|40.48622,-74.45182
  • New Brunswick, New Jersey, United States|40.48622,-74.45182

Key Eligibility Criteria

  • Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin
  • Tumor is HER2 negative by standard local testing methodology
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
  • Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1

For full eligibility, visit ClinicalTrials.gov.

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