Back to resultsEUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy
Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria: Diagnosed and histologically confirmed PDAC by biopsy Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter ECOG performance status 0-2 Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis Lesions between 1 - 4cm in size Exclusion Criteria: Patients that show evidence of distant metastasis Endoscopically non-accessible mass Pregnant patients Inability to provide informed consent Lesions <1cm, or >4cm in greatest diameter
Sites / Locations
- Tisch HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy plus EUS-RFA
Arm Description
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) and chemotherapy will be administered as part of standard of care treatment for PDAC in patients receiving palliative second- or third-line therapy for unresectable non-metastatic pancreatic cancer. Study participants will undergo 3 identical EUS-RFA procedures, administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11). During each EUS-RFA procedure, a tumor biopsy will also be taken for single cell RNA sequencing. Chemotherapy will be administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), Window 4 (Weeks 9-11), and Window 5 (Weeks 13-15).
Outcomes
Primary Outcome Measures
Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0
Per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, Grade III AEs are defined as severe or medically significant but not immediately life-threatening; or hospitalization or prolongation of hospitalization indicated; or disabling; or limiting self care activities of daily living. Grade IV AEs are defined as life-threatening consequences; or urgent intervention indicated.
Secondary Outcome Measures
Percentage of Participants who Complete all 3 EUS-RFA Treatments
Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11).
Disease-Free Survival from Diagnosis
Time from diagnosis to first clinical evidence of local or distant recurrence.
Disease-Free Survival from First Study Procedure
Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence.
Overall Survival From Diagnosis
Time from diagnosis to death.
Percentage of Participants who Report Post-Procedural Complications
Full Information
NCT ID
NCT05723107
First Posted
February 1, 2023
Last Updated
April 13, 2023
Sponsor
NYU Langone Health
Collaborators
Taewoong Medical
1. Study Identification
Unique Protocol Identification Number
NCT05723107
Brief Title
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
Official Title
Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Taewoong Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy plus EUS-RFA
Arm Type
Experimental
Arm Description
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) and chemotherapy will be administered as part of standard of care treatment for PDAC in patients receiving palliative second- or third-line therapy for unresectable non-metastatic pancreatic cancer.
Study participants will undergo 3 identical EUS-RFA procedures, administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11). During each EUS-RFA procedure, a tumor biopsy will also be taken for single cell RNA sequencing.
Chemotherapy will be administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), Window 4 (Weeks 9-11), and Window 5 (Weeks 13-15).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
Intervention Type
Device
Intervention Name(s)
Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
Other Intervention Name(s)
EUSRA RF Electrode
Intervention Description
EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator).
The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.
Primary Outcome Measure Information:
Title
Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0
Description
Per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, Grade III AEs are defined as severe or medically significant but not immediately life-threatening; or hospitalization or prolongation of hospitalization indicated; or disabling; or limiting self care activities of daily living. Grade IV AEs are defined as life-threatening consequences; or urgent intervention indicated.
Time Frame
Up to Week 15
Secondary Outcome Measure Information:
Title
Percentage of Participants who Complete all 3 EUS-RFA Treatments
Description
Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11).
Time Frame
Up to Week 11
Title
Disease-Free Survival from Diagnosis
Description
Time from diagnosis to first clinical evidence of local or distant recurrence.
Time Frame
Up to Week 24
Title
Disease-Free Survival from First Study Procedure
Description
Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence.
Time Frame
Up to Week 24
Title
Overall Survival From Diagnosis
Description
Time from diagnosis to death.
Time Frame
Up to Week 24
Title
Percentage of Participants who Report Post-Procedural Complications
Time Frame
Up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed and histologically confirmed PDAC by biopsy
Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter
ECOG performance status 0-2
Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis
Lesions between 1 - 4cm in size
Exclusion Criteria:
Patients that show evidence of distant metastasis
Endoscopically non-accessible mass
Pregnant patients
Inability to provide informed consent
Lesions <1cm, or >4cm in greatest diameter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamas A. Gonda, MD
Phone
212-263-3095
Email
Tamas.Gonda@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Agarunov
Phone
212-263-3095
Email
Emil.agarunov@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamas A. Gonda, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamas A. Gonda, MD
Phone
212-263-3095
Email
Tamas.Gonda@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Tamas.Gonda@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Tamas.Gonda@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
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