NCT07861386Active, not recruiting
Emulation of the MAVERICC Trial Using Specialty Oncology Electronic Health Records Databases
Emulation of the MAVERICC (NCT01374425) Trial Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 9978 (actual)
- First submitted
- 29 Sept 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 20 Oct 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07861386
What you commit to
- Study type: Observational
- Participants enrolled: 9978
- From 20 Aug 2026 to the primary completion date, 20 Oct 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
- Prior systemic treatment for metastatic colorectal cancer.
- Adjuvant chemotherapy within 12 months before study regimen initiation.
- Use of an investigational agent within 28 days before study regimen initiation.
Other illness
- Another primary malignancy within five years before study regimen initiation, except cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.
Other
- Evidence of brain metastases at or before study regimen initiation.
- Other anticancer treatment during the treatment assessment window, where ascertainable in the database.
Who the study is looking for
- Age 18 years or older at first-line study regimen initiation.
- Metastatic colorectal cancer documented in a specialty oncology electronic health record.
- Initiation of FOLFIRI plus bevacizumab or mFOLFOX6 plus bevacizumab as first-line systemic treatment for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 when ascertainable in the database.
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.