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CholangiocarcinomaPhase 1NCT04480190

Neoadjuvant Therapy in Biliary Adenocarcinoma

A Phase 1 study testing Gemcitabine, Cisplatin and Fluorouracil in people with Cholangiocarcinoma and Biliary Cancer, run by Jordan Kharofa at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Feasibility of neoadjuvant therapy in resectable biliary adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma, Biliary Cancer
What is being tested?
Gemcitabine, Cisplatin and Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
4 Feb 2021to 4 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

Other trials in United States

About this study

Official title: Feasibility of Total Neoadjuvant Therapy in Resectable Biliary Adenocarcinoma

Feasibility of neoadjuvant therapy in resectable biliary adenocarcinoma.

Read the 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.

Being tested
Gemcitabine, Cisplatin, Fluorouracil, Short course ChemoRT
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

    IV Gemcitabine 1000mg/m2 to be given on Days 1, Day 8 (Before Cisplatin); 3 week cycles

  • CisplatinDrug

    Also called Platinol

    IV Cisplatin 25mg/m2 to be given on Days 1, Day 8

  • FluorouracilDrug

    Also called 5FU

    Infusional 5-FU 225 mg/m2/d via Continuous IV infusion, to be given Days 1-5 and 8-12 during RT

  • Short course ChemoRTRadiation

    Also called 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.

Study groups in NCT04480190
Study groupRoleWhat they receive
Research TreatmentExperimentalGemcitabine/Cisplatin/ChemoRT
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Short course ChemoRT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Feasibility trial with accrual goal of 12 patients using primary endpoint of completion of neoadjuvant therapy and surgery as an assessment of feasibility. Interim assessment of first 6 patients enrolled will be performed. Resection rate benchmark for neoadjuvant pancreas trials ~70% accounting for patients found to have progression. Completion of all therapy is defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection. If 2 or less of first 6 patients enrolled complete all therapy the trial will be closed and treatment will be considered unfeasible. Upon trial completion, if 5 or less of 12 patients complete all therapy the trial will be deemed unfeasible.

    Measured: 5 years

Secondary outcomes (6)

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

    All patients will be evaluable for toxicity from the time of their first treatment with Gemcitabine/cisplatin using the CTCAE v 5 criteria.

    Measured: 5 years

  2. Margin negative resection rate. This will be measured by the Proportion of patients with involved surgical margins (R1 rate).

    This is one of the Pathologic outcomes that will be measured. The margin negative resection rate will be measured by the Proportion of patients with involved surgical margins (R1 rate).

    Measured: 5 years

  3. Lymph node involvement. This will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1).

    This is one of the Pathologic outcomes that will be measured. Lymph node involvement will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1).

    Measured: 5 years

  4. Survival outcomes measured by Disease Free Survival [DFS])

    Disease-free survival: From date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.

    Measured: 5 years

  5. Survival outcomes measured by Local Failure Free Survival [LFFS].

    Local failure free survival: From date of registration to date of first documentation of local relapse or death due to any cause. Patients last known to be alive and without evidence of local relapse will be censored at date of last contact.

    Local relapse: Any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).

    Measured: 5 years

  6. Survival outcomes measured by Overall Survival [OS].

    Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive will be censored at date of last contact.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start4 Feb 2021
  3. Primary completion4 Apr 2022
  4. Study completion4 Apr 2022

Why it stopped: Difficulty accruing

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480190
Sponsor's protocol ID
UCCC-GI-20-01
Status last verified
Apr 2022
First submitted
25 Jun 2020
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Cisplatin and Fluorouracil in people with Cholangiocarcinoma and Biliary Cancer, run by Jordan Kharofa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of all therapy. Defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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Neoadjuvant Therapy in Biliary Adenocarcinoma | AzTrials