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ACTIVE NOT RECRUITING
NCT07861360

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-09-24

Completion Date

2026-12-24

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

Initiation of trifluridine-tipiracil plus bevacizumab

Initiation of trifluridine-tipiracil (FTD-TPI) plus bevacizumab recorded in electronic health records is the exposure of interest. Treatment was selected in routine care, not assigned by this study.

DRUG

Initiation of trifluridine-tipiracil alone

Initiation of trifluridine-tipiracil (FTD-TPI) without bevacizumab recorded in electronic health records is the reference exposure. Treatment was selected in routine care, not assigned by this study.

Locations (1)

Brigham and Women's Hospital

Somerville, Massachusetts, United States