Pancreatic Locally Advanced Irresectable Cancer Ablation

NAUnknownINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

April 7, 2015

Primary Completion Date

November 30, 2019

Study Completion Date

May 31, 2020

Conditions
Locally Advanced Pancreatic Cancer
Interventions
PROCEDURE

Radiofrequency ablation (RFA)

RFA involves the implantation of electrodes directly into the tumor, with the use of intra-operative ultrasound. The electrodes produce a high frequency alternating current, which leads to frictional heating and thus tissue destruction by thermal coagulation and protein denaturation.

DRUG

FOLFIRINOX

Oxaliplatin 85mg/m2 given as 2-hour IV infusion, followed by leucovorin 400mg/m2 given as 2-hour IV infusion with addition of irinotecan 180mg/m2 given as 90-minute IV infusion. Followed by fluorouracil 400mg/m2 IV bolus, followed by continuous IV infusion of 2400mg/m2 during 46-hour. Every 2 weeks.

DRUG

Nab-paclitaxel plus Gemcitabine

Nab-paclitaxel 125mg/m2 given as 30-40-minute IV infusion, followed by gemcitabine 1000mg/m2 IV infusion. On day 1, 8 and 15 every 4 weeks.

DRUG

Gemcitabine

Gemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks.

Trial Locations (2)

1105 ZA

RECRUITING

Amsterdam UMC, Amsterdam

3508 GA

RECRUITING

Regionaal Academisch Kankercentrum Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dutch Cancer Society

OTHER

collaborator

Comprehensive Cancer Centre The Netherlands

OTHER

collaborator

Olympus

INDUSTRY

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

NCT03690323 - Pancreatic Locally Advanced Irresectable Cancer Ablation | Biotech Hunter | Biotech Hunter