Neoadjuvant Therapy in Biliary Adenocarcinoma

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Brief Title

Neoadjuvant Therapy in Biliary Adenocarcinoma

Official Title

Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma

Brief 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Completion of all therapy. Defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection.

Secondary Outcome

 Patients will be evaluated for toxicity during protocol therapy and postoperatively using the CTCAE v 5 criteria.

Condition

Cholangiocarcinoma

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Research Treatment
Description:  Gemcitabine/Cisplatin/ChemoRT

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

September 1, 2020

Completion Date

September 1, 2028

Primary Completion Date

September 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years.

          -  ECOG performance status ≤2

          -  Patients must have adequate organ and marrow function as defined below:

        leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total
        bilirubin ≤ 7 AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN OR
        glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2

          -  Known human immunodeficiency virus (HIV)-infected patients must be on effective
             anti-retroviral therapy with undetectable viral load within 6 months to be eligible
             for this trial.

          -  For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
             load must be undetectable on suppressive therapy, if indicated.

          -  Patients with a prior or concurrent malignancy whose natural history or treatment does
             not have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are eligible for this trial.

          -  Patients with known history or current symptoms of cardiac disease, or history of
             treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
             function using the New York Heart Association Functional Classification. To be
             eligible for this trial, patients should be class 2B or better.

          -  Patients must have either biopsy proven biliary adenocarcinoma (Intrahepatic
             cholangiocarcinoma, hilar cholangiocarcinoma, extrahepatic cholangiocarcinoma), or
             Gallbladder Adenocarcinoma or cytology with FISH abnormality sufficient for diagnosis.

          -  Patients must be deemed to have tumor that is resectable by the surgical oncologist
             and must have no medical contraindications to surgery.

          -  All patients must have a CT scan of the chest, abdomen, and pelvis with contrast or
             PET scan demonstrating no evidence of metastatic disease within 6 weeks prior to
             protocol therapy.

          -  Patients with enlarged regional lymph nodes within the dissection basin are eligible
             for participation.

          -  Women of child-bearing potential and men must agree to use adequate contraception for
             14 months (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation. Should a woman become pregnant or
             suspect she is pregnant while she or her partner is participating in this study, she
             should inform her treating physician immediately. Men treated or enrolled on this
             protocol must also agree to use adequate contraception prior to the study, for the
             duration of study participation, and 14 months after completion.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients with metastatic disease on imaging (biopsy not required).

          -  Patients not eligible for surgery due to tumor anatomy or medical comorbidities.

          -  Patients with known hypersensitivity to cisplatin, gemcitabine or 5-FU or any
             component of the formulation.

          -  Patients who have had chemotherapy or radiotherapy within 3 months prior to entering
             the study.

          -  Patients who have not recovered from adverse events due to prior anti-cancer therapy
             (i.e., have residual toxicities > Grade 1) with the exception of alopecia.

          -  Patients who are currently receiving any other investigational agents are excluded.
             Patients who received investigational agents prior to consenting to participate on
             this study who are no longer currently receiving those agents, are eligible.

          -  Patients with uncontrolled intercurrent illness that would prevent receipt of standard
             of care chemotherapy, radiation or surgery.

          -  Patients with psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant women are excluded from this study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jordan Kharofa, MD, 513-584-7698, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04480190

Organization ID

UCCC-GI-20-01


Responsible Party

Sponsor-Investigator

Study Sponsor

Jordan Kharofa


Study Sponsor

Jordan Kharofa, MD, Principal Investigator, University of Cincinnati


Verification Date

July 2020