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
0
Start Date
February 4, 2021
Completion Date
April 4, 2022
Primary Completion Date
April 4, 2022
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, ,
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
April 2022