NCT07861360Active, not recruiting
Emulation of the SUNLIGHT Trial Using Specialty Oncology Electronic Health Records Databases
Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (actual)
- First submitted
- 29 Sept 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 24 Nov 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07861360
What you commit to
- Study type: Observational
- Participants enrolled: 400
- From 24 Sept 2026 to the primary completion date, 24 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticancer treatment in the four weeks before study regimen initiation.
- Prior FTD-TPI use.
Other illness
- Another primary malignancy in the five years before or on study regimen initiation, except adequately treated cervical carcinoma in situ or basal cell skin cancer.
Other
- Other anticancer treatment during the treatment assessment window.
Who the study is looking for
- Age 18 years or older at study regimen initiation.
- Metastatic colorectal cancer documented in the oncology electronic health record.
- Initiation of trifluridine-tipiracil (FTD-TPI) plus bevacizumab or FTD-TPI alone after two prior systemic treatment regimens for metastatic disease (third-line setting).
- Known RAS mutation status at or before study regimen initiation.
- Prior treatments included a fluoropyrimidine, irinotecan, and oxaliplatin. Prior anti-VEGF therapy was required for RAS-mutant disease; prior anti-VEGF or anti-EGFR therapy was required for RAS wild-type disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 when ascertainable in the electronic health record.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.