Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03257033

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

Led by RenovoRx · Updated on 2025-11-14

190

Participants Needed

42

Research Sites

442 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytopathology confirmed pancreatic adenocarcinoma diagnosed within 8 weeks before consent or start of chemotherapy
  • Locally advanced, unresectable disease confirmed by imaging and multidisciplinary team
  • ECOG Performance Status of 0 or 1
  • Age 18 years or older
  • Adequate blood counts and organ function before starting chemotherapy
  • Life expectancy greater than 12 weeks
  • Negative pregnancy test for women of childbearing potential and use of effective contraception during and 6 months after treatment
  • Willingness to participate in the study for at least 8 months if randomized
Not Eligible

You will not qualify if you...

  • Previous treatment for pancreatic cancer beyond one cycle of gemcitabine and nab-paclitaxel
  • Evidence of metastatic disease or another active cancer within the past year, except certain in situ cancers
  • Unable or unwilling to begin randomized treatment within specified timeframes
  • Lack of baseline tumor imaging
  • Unsuitable arterial anatomy for intra-arterial chemotherapy delivery
  • Contraindications for stereotactic body radiation therapy (SBRT)
  • Known HIV infection or active viral hepatitis
  • Recent severe infections or signs of infection prior to treatment
  • Allergic reactions to gemcitabine or nab-paclitaxel
  • Recent anti-cancer therapies or herbal anti-cancer treatments
  • Uncontrolled seizures
  • Serious cardiovascular disease or heart failure within 3 months
  • Other severe diseases or conditions limiting study participation
  • Recent surgeries or procedures within specified timeframes
  • Breastfeeding women
  • Inability or unwillingness to use effective contraception during and 6 months after treatment
  • Use of other investigational agents within 2 weeks prior to treatment
  • Social or psychiatric issues that may affect compliance
  • Inability or unwillingness to undergo catheterization procedures required by the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 42 locations

1

VA Loma Linda Healthcare System

Loma Linda, California, United States, 92357

Terminated

2

Sutter Cancer Center Sacramento

Sacramento, California, United States, 95816

Actively Recruiting

3

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

Withdrawn

4

Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC

Englewood, Colorado, United States, 80113

Withdrawn

5

Sibley Memorial Hospital - a member of Johns Hopkins medicine

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

6

Georgetown University

Washington D.C., District of Columbia, United States, 20057

Withdrawn

7

21st Century Oncology

Fort Myers, Florida, United States, 33907

Terminated

8

Miami Cancer Center

Miami, Florida, United States, 33167

Actively Recruiting

9

Sarasota Memorial Health Care System

Sarasota, Florida, United States, 34329

Actively Recruiting

10

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Terminated

11

ASCLEPES Research Centers

Weeki Wachee, Florida, United States, 34607

Terminated

12

Piedmont-Columbus Regional - John B. Amos Cancer Center

Columbus, Georgia, United States, 31904

Withdrawn

13

University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

14

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Withdrawn

15

LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Withdrawn

16

Medstar Franklin Square

Baltimore, Maryland, United States, 21237

Terminated

17

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

18

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766

Terminated

19

MD Anderson Cancer Center at Cooper Hospital

Camden, New Jersey, United States, 08103

Terminated

20

Atlantic Health System - Morristown Medical Center

Morristown, New Jersey, United States, 07960

Withdrawn

21

Albany Stratton VA Medical Center

Albany, New York, United States, 12208

Withdrawn

22

Feinstein Institutes for Medical Research - Northwell Health

Manhasset, New York, United States, 11030

Actively Recruiting

23

Columbia University Medical Center

New York, New York, United States, 10032

Active, Not Recruiting

24

Montefiore Hospital

The Bronx, New York, United States, 10461

Terminated

25

Levine Cancer Institute - Atrium Health

Charlotte, North Carolina, United States, 28204

Actively Recruiting

26

East Carolina University

Greenville, North Carolina, United States, 27834

Actively Recruiting

27

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Active, Not Recruiting

28

Oklahoma University - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

29

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

30

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

31

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, United States, 29425

Active, Not Recruiting

32

Prisma Health (formerly Greenville Health System)

Greenville, South Carolina, United States, 29605

Actively Recruiting

33

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Withdrawn

34

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

35

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108

Withdrawn

36

West Virginia University Medicine

Morgantown, West Virginia, United States, 26506

Actively Recruiting

37

AZ Sint-Lucas

Bruges, Belgium, 8310

Terminated

38

UZ Antwerp

Edegem, Belgium, 2650

Terminated

39

AZ Maria Middelares

Ghent, Belgium, 9000

Terminated

40

UZ Gent

Ghent, Belgium, 9000

Withdrawn

41

Jolimont Hospital

La Louvière, Belgium, 7100

Terminated

42

AZ Delta

Roeselare, Belgium, 8800

Terminated

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Research Team

N

Nicki Keller

CONTACT

L

Leesa Gentry

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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