Metastatic Colorectal Cancer (mCRC)NCT07861360
Emulation of the SUNLIGHT Trial Using Specialty Oncology Electronic Health Records Databases
An observational study of Metastatic Colorectal Cancer (mCRC), run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- Initiation of trifluridine-tipiracil plus bevacizumab and Initiation of trifluridine-tipiracil alone
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to 24 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with metastatic colorectal cancer who initiated FTD-TPI plus bevacizumab or FTD-TPI alone after two prior systemic treatment regimens for metastatic disease.
Who may be able to join
- 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.
Who cannot join
- Anticancer treatment in the four weeks before study regimen initiation.
- 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.
- Prior FTD-TPI use.
- Other anticancer treatment during the treatment assessment window.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Somerville, Massachusetts, 02145
About this study
Official title: Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases
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.
Read the detailed description
Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to complement evidence from RCTs. Yet, to have confidence in the accuracy of non-interventional studies of medical products and their outcomes in oncology, investigators need to know what questions can be validly answered, with which non-interventional study designs, and which analysis methods are appropriate, given the data that is available. Building on a process from the RCT DUPLICATE initiative, EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) is the trial emulation discussed in this protocol, which is part of the expansion project specific to oncology and aims to emulate 12 randomized oncology RCTs using multiple EHR data sources.
The purpose of this protocol is to describe the emulation of the SUNLIGHT trial.5 SUNLIGHT was a Phase III, open-label, randomised study assessing the efficacy and safety of trifluridine-tipiracil (FTD-TPI) (35 mg/m²/dose orally BID; Given 5 days on / 2 days off schedule, for 2 weeks, followed by 14-day rest) plus bevacizumab (5 mg/kg intravenously on Day 1 and Day 15, every 4-week cycle) versus FTD-TPI alone (35 mg/m²/dose orally BID; Given 5 days on / 2 days off schedule, for 2 weeks, followed by 14-day rest) in patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- Initiation of trifluridine-tipiracil plus bevacizumab, Initiation of trifluridine-tipiracil alone
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of trifluridine-tipiracil plus bevacizumabDrug
Also called FTD-TPI 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.
Initiation of trifluridine-tipiracil aloneDrug
Also called FTD-TPI 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.
| Study group | Role | What they receive |
|---|---|---|
| Initiation of trifluridine-tipiracil plus bevacizumab | Not described Receives: Drug: Initiation of trifluridine-tipiracil plus bevacizumab | |
| Initiation of trifluridine-tipiracil alone | Not described Receives: Drug: Initiation of trifluridine-tipiracil alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause mortality (overall survival)
Hazard ratio with 95% confidence interval
Measured: From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on the oncology registry data provider; end of data ranges from September 2023 to February 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start24 Sep 2026
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley V Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861360
- Sponsor's protocol ID
- 2022P002556-ENC-SUNLIGHT
- Other IDs
- 75F40122C00181
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases
- ClinicalTrials.gov ID
- NCT07861360
- Acronym / sponsor ID
- 2022P002556-ENC-SUNLIGHT
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to complement evidence from RCTs. Yet, to have confidence in the accuracy of non-interventional studies of medical products and their outcomes in oncology, investigators need to know what questions can be validly answered, with which non-interventional study designs, and which analysis methods are appropriate, given the data that is available. Building on a process from the RCT DUPLICATE initiative, EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) is the trial emulation discussed in this protocol, which is part of the expansion project specific to oncology and aims to emulate 12 randomized oncology RCTs using multiple EHR data sources.
The purpose of this protocol is to describe the emulation of the SUNLIGHT trial.5 SUNLIGHT was a Phase III, open-label, randomised study assessing the efficacy and safety of trifluridine-tipiracil (FTD-TPI) (35 mg/m²/dose orally BID; Given 5 days on / 2 days off schedule, for 2 weeks, followed by 14-day rest) plus bevacizumab (5 mg/kg intravenously on Day 1 and Day 15, every 4-week cycle) versus FTD-TPI alone (35 mg/m²/dose orally BID; Given 5 days on / 2 days off schedule, for 2 weeks, followed by 14-day rest) in patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initiation of trifluridine-tipiracil plus bevacizumab | – | Drug: Initiation of trifluridine-tipiracil plus bevacizumab |
| Initiation of trifluridine-tipiracil alone | – | Drug: Initiation of trifluridine-tipiracil alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with metastatic colorectal cancer who initiated FTD-TPI plus bevacizumab or FTD-TPI alone after two prior systemic treatment regimens for metastatic disease.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Anticancer treatment in the four weeks before study regimen initiation.
- 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.
- Prior FTD-TPI use.
- Other anticancer treatment during the treatment assessment window.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initiation of trifluridine-tipiracil plus bevacizumabAlso: FTD-TPI plus bevacizumabInitiation 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 plus bevacizumab |
| Initiation of trifluridine-tipiracil aloneAlso: FTD-TPI aloneInitiation 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. | Drug | Initiation of trifluridine-tipiracil alone |
Primary outcome
Time to all-cause mortality (overall survival)
Time frame: From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on the oncology registry data provider; end of data ranges from September 2023 to February 2026)
Hazard ratio with 95% confidence interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley V Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer (mCRC), run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to all-cause mortality (overall survival) (time frame: From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on the oncology registry data provider; end of data ranges from September 2023 to February 2026)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.