Using ultrasound-guided radiofrequency ablation with chemotherapy for pancreatic cancer treatment
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
This study is testing if combining a special ultrasound treatment with chemotherapy can help shrink pancreatic cancer tumors before surgery to make the surgery easier and more successful for patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04990609 on ClinicalTrials.gov |
What this trial studies
This trial investigates the feasibility and effectiveness of combining endoscopic ultrasound (EUS) radiofrequency ablation (RFA) with standard neoadjuvant chemotherapy (NAC) for patients with pancreatic ductal adenocarcinoma (PDAC). The approach aims to shrink tumors or halt cancer progression before surgical resection, potentially making the surgery less invasive and more successful. Participants will receive EUS-RFA followed by NAC, with careful monitoring of treatment tolerability and outcomes. The study seeks to establish a new treatment protocol that could improve patient prognosis.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with histologically-confirmed PDAC who have not undergone prior chemotherapy.
Not a fit: Patients under 18 years old, pregnant individuals, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with pancreatic cancer by making surgery more effective.
How similar studies have performed: While the combination of EUS-RFA and NAC is a novel approach, similar studies have shown promise in improving outcomes for patients with other types of cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed and histologically-confirmed PDAC by biopsy * Permanent street address * Consent to study participation * Axial CT scan consistent with PDAC * No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: * Male or female patients \< 18 years of age * No permanent street address or telephone number * Pregnant patients * Inmates or prisoners * Unable to provide informed consent
Where this trial is running
Houston, Texas
- Memorial Hermann Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nirav Thosani, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Sofia C Colon, BS
- Email: Sofia.C.Colon@uth.tmc.edu
- Phone: 713-500-6658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.