EUS-Guided RFA + Chemotherapy for Pancreatic Cancer
(PANCARDINAL-1 Trial)
Trial Summary
What is the purpose of this trial?
The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment EUS-Guided RFA + Chemotherapy for Pancreatic Cancer?
Is EUS-Guided RFA + Chemotherapy safe for humans?
The research articles primarily discuss the safety of neoadjuvant chemotherapy (NAC) for pancreatic cancer, indicating that it is generally well tolerated with some manageable side effects like low white blood cell count and low platelet count. However, there is no specific safety data available for EUS-Guided Radiofrequency Ablation (RFA) combined with chemotherapy in these studies.13467
How is the treatment EUS-Guided RFA + Chemotherapy for Pancreatic Cancer different from other treatments?
This treatment combines EUS-guided RFA (a technique using heat to destroy cancer cells) with neoadjuvant chemotherapy (NAC), which is given before surgery to shrink tumors and improve surgical outcomes. This combination is unique because it integrates a local treatment (RFA) with systemic chemotherapy, potentially enhancing the effectiveness of preoperative cancer management.12358
Research Team
Nirav Thosani, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy and EUS-RFA
Participants receive neoadjuvant chemotherapy and endoscopic ultrasound-guided radiofrequency ablation to shrink the tumor or stop the spread of cancer before surgery
Surgery
Tumor resection surgery is performed after neoadjuvant treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including radiographic treatment response assessment using RECIST criteria
Long-term Follow-up
Participants are monitored for disease-free survival time, up to 5 years after diagnosis
Treatment Details
Interventions
- Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
- Endoscopic Ultrasound (EUS) Radiofrequency Ablation (RFA)
- Neoadjuvant chemotherapy (NAC)
Neoadjuvant chemotherapy (NAC) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Pancreatic cancer
- Lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
National Cancer Institute (NCI)
Collaborator