RecruitingPhase 3NCT03257033

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer

Sponsor

RenovoRx

Enrollment

190 participants

Start Date

Mar 12, 2018

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Pancreatic Cancer

Summary

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to delivering chemotherapy to patients with locally advanced pancreatic cancer that cannot be surgically removed: giving the drug directly into the artery feeding the tumor (intra-arterial) versus the standard method of putting it into a vein (intravenous), after an initial course of radiation and chemotherapy. **You may be eligible if...** - You have been confirmed (by biopsy or cell sample) to have pancreatic cancer that cannot be removed with surgery - You are 18 or older and in reasonably good physical condition - Your blood counts, liver function, and kidney function meet the required levels - You are willing to use contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have had any prior treatment for pancreatic cancer beyond one cycle of the initial chemotherapy regimen - Your cancer has spread to other parts of the body - You have had a recent heart attack, stroke, or severe heart failure within the last 3 months - You have HIV or active hepatitis - You have had major surgery within 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

Chemotherapy

DRUGnab-paclitaxel

Chemotherapy

DEVICERenovoCath

Intra-arterial catheter

Locations(42)

VA Loma Linda Healthcare System

Loma Linda, California, United States

Sutter Cancer Center Sacramento

Sacramento, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC

Englewood, Colorado, United States

Sibley Memorial Hospital - a member of Johns Hopkins medicine

Washington D.C., District of Columbia, United States

Georgetown University

Washington D.C., District of Columbia, United States

21st Century Oncology

Fort Myers, Florida, United States

Miami Cancer Center

Miami, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

ASCLEPES Research Centers

Weeki Wachee, Florida, United States

Piedmont-Columbus Regional - John B. Amos Cancer Center

Columbus, Georgia, United States

University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

LSU Health Shreveport

Shreveport, Louisiana, United States

Medstar Franklin Square

Baltimore, Maryland, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

MD Anderson Cancer Center at Cooper Hospital

Camden, New Jersey, United States

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, United States

Albany Stratton VA Medical Center

Albany, New York, United States

Feinstein Institutes for Medical Research - Northwell Health

Manhasset, New York, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Hospital

The Bronx, New York, United States

Levine Cancer Institute - Atrium Health

Charlotte, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Oklahoma University - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, United States

Prisma Health (formerly Greenville Health System)

Greenville, South Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

West Virginia University Medicine

Morgantown, West Virginia, United States

AZ Sint-Lucas

Bruges, Belgium

UZ Antwerp

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

UZ Gent

Ghent, Belgium

Jolimont Hospital

La Louvière, Belgium

AZ Delta

Roeselare, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03257033

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