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Emulation of the MAVERICC Trial Using Specialty Oncology Electronic Health Records Databases
Sponsor: Brigham and Women's Hospital
Summary
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).
Official title: Emulation of the MAVERICC (NCT01374425) Trial Using Specialty Oncology Electronic Health Records Databases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
9978
Start Date
2026-08-20
Completion Date
2026-10-20
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
FOLFIRI plus bevacizumab
Observed initiation of first-line FOLFIRI (leucovorin, fluorouracil, and irinotecan) plus bevacizumab for metastatic colorectal cancer in routine care. Treatment was not assigned by this observational study.
mFOLFOX6 plus bevacizumab
Observed initiation of first-line mFOLFOX6 (modified leucovorin, fluorouracil, and oxaliplatin) plus bevacizumab for metastatic colorectal cancer in routine care. Treatment was not assigned by this observational study.
Locations (1)
Brigham and Women's Hospital
Somerville, Massachusetts, United States