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A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer (DIRECT)

Primary Purpose

Stage III Pancreatic Cancer

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Modified FOLFIRINOX Regimen

NanoKnife System

About this trial

This is an interventional treatment trial for Stage III Pancreatic Cancer focused on measuring Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor, Pancreatic Carcinoma, Unresectable Pancreatic Cancer, LAPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form.
Subject is 18 years of age and older.
Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
Subject has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receiving three months of treatment with the modified FOLFIRINOX regimen.
Subject has received 3 months of treatment with the modified FOLFIRINOX regimen.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.

Exclusion Criteria:

Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy.
Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade.
Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000.
Subjects with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.
Subjects with history of epilepsy or other neurological disease.
Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator.
Subjects with Stage 3, 4, or 5 chronic kidney disease.
Subjects receiving IRE for margin accentuation.
Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression.
Participation in another interventional trial for pancreatic cancer.
Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months.

Sites / Locations

Miami Cancer InstituteRecruiting
University of South Florida/TampaRecruiting
Northwest Community HealthcareRecruiting
Norton HealthcareRecruiting
St. Luke's Cancer CenterRecruiting
University of Texas-SouthwesternRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRE

Control

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Time (in months) from randomization to the date of death for any reason

Secondary Outcome Measures

Full Information

NCT ID

NCT03899636

First Posted

March 29, 2019

Last Updated

November 23, 2022

Sponsor

Angiodynamics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03899636

Brief Title

A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

Acronym

DIRECT

Official Title

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Angiodynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Pancreatic Cancer

Keywords

Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor, Pancreatic Carcinoma, Unresectable Pancreatic Cancer, LAPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IRE

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Modified FOLFIRINOX Regimen

Intervention Description

Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin

Intervention Type

Device

Intervention Name(s)

NanoKnife System

Intervention Description

IRE using NanoKnife System

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time (in months) from randomization to the date of death for any reason

Time Frame

Time (in months) from randomization to the date of death for any reason, assessed through at least 24 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form. Subject is 18 years of age and older. Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria. Subject has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receiving three months of treatment with the modified FOLFIRINOX regimen. Subject has received 3 months of treatment with the modified FOLFIRINOX regimen. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2. Exclusion Criteria: Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy. Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000. Subjects with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE. Subjects with history of epilepsy or other neurological disease. Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator. Subjects with Stage 3, 4, or 5 chronic kidney disease. Subjects receiving IRE for margin accentuation. Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression. Participation in another interventional trial for pancreatic cancer. Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Manning

Phone

(339) 237-2765

liz.manning@angiodynamics.com

Facility Information:

Facility Name

Miami Cancer Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Govindarajan Narayanan, MD

Facility Name

University of South Florida/Tampa

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thanh Tran

First Name & Middle Initial & Last Name & Degree

Vic Velanovich, MD

Facility Name

Northwest Community Healthcare

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henry Mantakul

First Name & Middle Initial & Last Name & Degree

Malcolm Bilimoria, MD

Facility Name

Norton Healthcare

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Healey

Facility Name

St. Luke's Cancer Center

City

Easton

State/Province

Pennsylvania

ZIP/Postal Code

18045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janine Schippang

First Name & Middle Initial & Last Name & Degree

Darius Desai, MD

Facility Name

University of Texas-Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Misbah Shabbir

First Name & Middle Initial & Last Name & Degree

Patricio Polanco, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34233640

Citation

Narayanan G, Bilimoria MM, Hosein PJ, Su Z, Mortimer KM, Martin RCG 2nd. Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife(R) system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols. BMC Cancer. 2021 Jul 7;21(1):785. doi: 10.1186/s12885-021-08474-4.

Results Reference

derived

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A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

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