NCT04480190

Neoadjuvant Therapy in Biliary Adenocarcinoma

Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jordan Kharofa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility of neoadjuvant therapy in resectable biliary adenocarcinoma.

Detailed 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 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.

Conditions

• Cholangiocarcinoma
• Biliary Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	IV Gemcitabine 1000mg/m2 to be given on Days 1, Day 8 (Before Cisplatin); 3 week cycles
DRUG	Cisplatin	IV Cisplatin 25mg/m2 to be given on Days 1, Day 8
DRUG	Fluorouracil	Infusional 5-FU 225 mg/m2/d via Continuous IV infusion, to be given Days 1-5 and 8-12 during RT
RADIATION	Short course ChemoRT	Radiation Therapy: Sim: All patients will undergo 4D-CT simulation with 3 hours fasting with or without IV contrast. Compression may be used depending on the tumor motion. Radiation Target Volume: The gross tumor volume (GTV) will be defined on all relevant imaging datasets including diagnostic CT, MRI, MRCP and/or ERCP data. An iGTV will be generated using the 4D datasets. The clinical target volume (CTV) will include the entire iGTV as well as portal lymphatic and celiac nodal space for all patients with selective treatment of the SMA and pancreaticoduodenal depending on the tumor location. A 5 mm margin will be added to the CTV to generate the planning target volume (PTV). Radiation Dose: The dose will be 30 Gy in 10 fractions (3 Gy per fraction) for all patients using either 3D Conformal or Intensity Modulated Radiation Therapy techniques.

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2020-07-21
• Last updated: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study