Emulation of the MAVERICC 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 trial emulation study aims to emulate the MAVERICC trial (NCT01374425) using real-world specialty oncology electronic health record data and to investigate the concordance between the trial's original and emulated treatment effect estimates on overall survival (OS). MAVERICC was a Phase II, open-label, randomized study assessing the efficacy and safety of modified leucovorin/5-fluorouracil/ oxaliplatin plus bevacizumab (mFOLFOX6-BV) with leucovorin/5-fluorouracil/irinotecan plus bevacizumab (FOLFIRI-BV) in patients with previously untreated metastatic colorectal cancer (mCRC).
Trial Details
NCT Number NCT07861386
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 9,978 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov