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Chemotherapy
Chemo + EUS-RFA for Pancreatic Cancer
Phase 1
Recruiting
Led By Tamas A. Gonda, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lesions between 1 - 4cm in size
Diagnosed and histologically confirmed PDAC by biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 24
Awards & highlights
Study Summary
This trial tests a chemo + EUS-RFA combo to treat pancreatic cancer. It's used in palliative care for cancer that's not removable and not spread.
Who is the study for?
This trial is for individuals with pancreatic cancer that hasn't spread far (locally advanced) and is between 1-4cm in size. They should have tried chemotherapy already without success, be reasonably well (ECOG 0-2), and not be candidates for surgery. Pregnant people or those who can't consent, have tumors smaller than 1cm or larger than 4cm, or masses that can't be reached endoscopically are excluded.Check my eligibility
What is being tested?
The study tests how well patients handle a combination of chemotherapy and a procedure called Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA). It's given to those whose pancreatic cancer remains after initial chemo but hasn’t metastasized.See study design
What are the potential side effects?
Possible side effects include discomfort from the EUS-RFA procedure, typical chemotherapy-related issues like nausea, fatigue, hair loss, increased infection risk, and potential complications from the ablation such as pancreatitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer lesion is between 1 to 4 cm in size.
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My pancreatic cancer diagnosis was confirmed through a biopsy.
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I can take care of myself and perform daily activities.
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My scan shows a pancreatic tumor larger than 1 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0
Secondary outcome measures
Disease-Free Survival from Diagnosis
Disease-Free Survival from First Study Procedure
Overall Survival From Diagnosis
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Chemotherapy plus EUS-RFAExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,552 Total Patients Enrolled
Taewoong MedicalUNKNOWN
Tamas A. Gonda, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.My cancer lesion is between 1 to 4 cm in size.My pancreatic cancer diagnosis was confirmed through a biopsy.I can take care of myself and perform daily activities.My scan shows a pancreatic tumor larger than 1 cm.My advanced pancreatic cancer hasn't spread far and didn't improve with first chemotherapy.My cancer lesions are either smaller than 1cm or larger than 4cm.My tumor cannot be reached with an endoscope.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy plus EUS-RFA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks arise from the combination of Chemotherapy and EUS-RFA?
"Our team assigned Chemotherapy plus EUS-RFA a score of 1 due to the preliminary evidence demonstrating its safety and effectiveness; this is a Phase 1 study."
Answered by AI
Are there any opportunities for new participants in this experiment?
"Confirmed, this trial is not actively seeking participants. In fact, the clinical trial was posted on March 1st of 2023 and had its last edit made February 9th of that same year. While no individuals are being recruited presently for this study, there are 701 other medical studies currently in search of volunteers."
Answered by AI
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