Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

March 3, 2020 updated by: Zhiqiang Meng, Fudan University

A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome Measures:

To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.

Secondary Outcome Measures:

To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.

Exploratory Outcome Measures:

To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhiqiang Meng, MD, Ph D
        • Sub-Investigator:
          • Yehua Shen, MD, Ph D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
  • Measurable disease by RECIST criteria must be present.
  • Karnofsky Performance Status ≥ 70
  • Patients with adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal

  • Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
  • Patients with jaundice must have a biliary drainage decompression operation before recruitment.
  • Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Subject with metastatic disease.
  • Prior treatment with systemic chemotherapy.
  • Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
  • Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
  • Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
  • Concurrent infection requiring intravenous antibiotics.
  • Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
  • Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
  • Known central nervous system involvement and leptomeningeal disease
  • Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAI chemotherapy
Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
Drug: Gemcitabine
Procedure: Transcatheter arterial infusion
Drug: Oxaliplatin
Active Comparator: Chemotherapy
Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.
Drug: Gemcitabine
Drug: Oxaliplatin
Procedure: Intravenous chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death, assessed up to 100 months.
From date of randomization until the date of death, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhiqiang Meng, MD, Ph D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAI-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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