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sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 1, 2026 → Feb 1, 2027
See other at-risk trials from Rutgers, The State University of New Jersey

Record History

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  1. Primary completion pushed from Aug 1, 2026 to Feb 1, 2027
    • Study completion pushed from Aug 1, 2026 to Aug 1, 2027
    • Eligibility criteria expanded, about 29 words
  2. Primary and study completion dates: Aug 1, 2025 to Aug 1, 2026v6
  3. Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025
    • Study sites: 7 to 6
    v5
  4. Study sites: 1 to 7v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2022 to Jul 13, 2022
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05332002
Lead Sponsor Rutgers, The State University of New Jersey
Conditions
(from sponsor)		 Gastro-Intestinal Cancer
Related terms Esophageal Neoplasms
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov