Emulation of the SUNLIGHT Trial Using Specialty Oncology Electronic Health Records Databases

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

  1. Re-verified, no change to tracked fields
  2. Study First Submitted
This observational study uses existing U.S. specialty oncology electronic health records to emulate the SUNLIGHT trial. It compares survival among adults with metastatic colorectal cancer who began trifluridine-tipiracil plus bevacizumab or trifluridine-tipiracil alone after prior systemic treatment. Treatment was chosen during routine care; the study did not assign treatment. The main outcome is time to death from any cause. Investigators will compare the real-world estimate with the published estimate from the randomized SUNLIGHT trial.
Trial Details
NCT Number NCT07861360
Lead Sponsor Brigham and Women's Hospital
Collaborators: Food and Drug Administration (FDA)
Conditions
(from sponsor)		 Metastatic Colorectal Cancer (mCRC)
Related terms Colorectal Neoplasms
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov