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Anti-metabolites

EUS-Guided RFA + Chemotherapy for Pancreatic Cancer (PANCARDINAL-1 Trial)

Phase 2

Recruiting

Led By Nirav Thosani

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of eus-rfa nac intervention to the time of surgical tumor resection (about 5-6 months)

Awards & highlights

PANCARDINAL-1 Trial Summary

This trial will study whether the combination of Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) and Neoadjuvant chemotherapy (NAC) is a feasible and tolerable treatment for Pancreatic Ductal Adenocarcinoma (PDAC), and what effect it has on the tumor.

Who is the study for?

This trial is for adults with pancreatic cancer confirmed by biopsy, who are in fair to good physical condition (ECOG 0-2), and have either not had chemotherapy or less than two months of it. They must have a permanent address and agree to participate. It's not open to prisoners, those without a phone number, anyone unable to consent, or pregnant individuals.Check my eligibility

What is being tested?

The study tests the combination of Endoscopic Ultrasound-guided Radiofrequency Ablation (EUS-RFA) with standard Neoadjuvant chemotherapy (NAC). The goal is to shrink the tumor before surgery, potentially making the operation less invasive and more successful.See study design

What are the potential side effects?

Possible side effects include discomfort from the EUS-RFA procedure such as abdominal pain or pancreatitis, and typical chemotherapy-related issues like nausea, fatigue, hair loss, increased infection risk due to lowered white blood cell counts.

PANCARDINAL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had chemotherapy, or had less than 2 months of it for pancreatic cancer.

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I am able to get out of my bed or chair and move around.

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My pancreatic cancer diagnosis was confirmed through a biopsy.

PANCARDINAL-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of eus-rfa nac intervention to the time of surgical tumor resection (about 5-6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of eus-rfa nac intervention to the time of surgical tumor resection (about 5-6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of eus-rfa nac intervention to the time of surgical tumor resection (about 5-6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection

Secondary outcome measures

Disease-free survival time

Number of participants with post-operative complications

Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria

PANCARDINAL-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant chemotherapy (NAC) plus Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA)Experimental Treatment2 Interventions

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,982 Total Patients Enrolled

Nirav ThosaniPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Neoadjuvant chemotherapy (NAC) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04990609 — Phase 2

Pancreatic Cancer Research Study Groups: Neoadjuvant chemotherapy (NAC) plus Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA)

Pancreatic Cancer Clinical Trial 2023: Neoadjuvant chemotherapy (NAC) Highlights & Side Effects. Trial Name: NCT04990609 — Phase 2

Neoadjuvant chemotherapy (NAC) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04990609 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please elucidate the potential risks of Neoadjuvant chemotherapy (NAC)?

"There is some data indicating Neoadjuvant chemotherapy's safety, which means it was given a score of 2 on the scale. That being said, there are no clinical studies that validate its efficacy."

Answered by AI

What is the current number of participants involved in this experiment?

"Affirmative, the clinicaltrials.gov webpage confirms that this trial is currently searching for volunteers. This study was first published on July 23rd 2021 and has been revised most recently on September 20th 2021. 15 individuals are needed to take part in trials at a single site."

Answered by AI

Is this research endeavor still seeking participants?

"As per the data on clinicaltrials.gov, this trial is presently enrolling participants; it was initially published on July 23rd 2021 and underwent a recent update September 20th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer

Nirav C Thosani 2021. "A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990609.