Neoadjuvant Therapy in Biliary Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Biliary Cancer
- Cholangiocarcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This trial will evaluate whether a neoadjuvant paradigm is feasible in resectable biliary adenocarcinoma. All components of therapy are currently used standards of care, however they have not been used in the neoadjuvant setting for the management of resectable biliary cancers. The study will use Ge...
This trial will evaluate whether a neoadjuvant paradigm is feasible in resectable biliary adenocarcinoma. All components of therapy are currently used standards of care, however they have not been used in the neoadjuvant setting for the management of resectable biliary cancers. The study will use Gemcitabine/cisplatin, followed by chemoradiation. This is a feasibility trial with an accrual goal of 12 patients using the primary endpoint of completion of neoadjuvant therapy and surgery as an assessment of feasibility.
Tracking Information
- NCT #
- NCT04480190
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jordan Kharofa, MD University of Cincinnati
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