60 Participants Needed

EUS-Guided RFA + Chemotherapy for Pancreatic Cancer

(PANCARDINAL-1 Trial)

NT
PB
PB
NT
SC
Overseen BySofia C Colon, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center, Houston
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that neoadjuvant chemotherapy (NAC) can help shrink tumors in pancreatic cancer, making surgery more successful. This suggests that combining NAC with other treatments like EUS-Guided RFA might improve outcomes for patients.12345

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

NT

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

Axial CT scan consistent with PDAC
Permanent street address and consent to study participation
I have not had chemotherapy, or had less than 2 months of it for pancreatic cancer.
See 2 more

Exclusion Criteria

I am unable to understand and give consent for treatment.
Inmates or prisoners
I am over 18 years old.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks

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

2 months

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)
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)Experimental Treatment2 Interventions

Neoadjuvant chemotherapy (NAC) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Neoadjuvant chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Lung cancer
🇺🇸
Approved in United States as Neoadjuvant chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Lung cancer
🇨🇦
Approved in Canada as Neoadjuvant chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Lung cancer
🇯🇵
Approved in Japan as Neoadjuvant chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Lung cancer
🇨🇳
Approved in China as Neoadjuvant chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Pancreatic cancer
  • Lung cancer
🇨🇭
Approved in Switzerland as Neoadjuvant chemotherapy for:
  • 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

Trials
974
Recruited
361,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Neoadjuvant chemotherapy (NAC) significantly reduces lymphatic tissue invasion in patients with borderline-resectable pancreatic cancer, with lower rates of lymph node invasion (51.5% vs. 72.7%) and lymphatic vessel invasion (9.4% vs. 55.3%) compared to those undergoing upfront surgery.
NAC is a safe treatment option, showing no increase in perioperative complications, hospital stay, or mortality, and it even resulted in a lower occurrence of postoperative pancreatic fistula (18.2% vs. 24.3%).
Neoadjuvant Chemotherapy Enhances Local Postoperative Histopathological Tumour Stage in Borderline Resectable Pancreatic Cancer - A Matched-Pair Analysis.Timmermann, L., Rosumeck, N., Klein, F., et al.[2023]
In a study of 586 patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC), neoadjuvant chemotherapy (NAC) showed a significant overall survival (OS) benefit when measured from diagnosis, particularly for those achieving an optimal CA19-9 response, which was defined as normalization and over 50% reduction in levels.
Patients with an optimal CA19-9 response had a notably longer OS (39.3 months) compared to those with suboptimal responses (21.5 months) and those who underwent surgery-first (SF) (19.5 months), suggesting that CA19-9 response could be a key marker for the effectiveness of NAC.
No survival benefit with suboptimal CA19-9 response: defining effective neoadjuvant chemotherapy in resectable or borderline resectable pancreatic cancer.Liu, H., D'Alesio, M., AlMasri, S., et al.[2023]
In a study of 468 patients with borderline resectable or locally advanced pancreatic cancer, switching chemotherapy regimens after initial treatment allowed 72% of those patients to undergo curative surgery, demonstrating its potential benefit in treatment planning.
Overall survival and recurrence-free survival rates were similar between patients who continued with the first-line chemotherapy and those who switched, indicating that changing chemotherapy regimens does not negatively impact oncologic outcomes.
Neoadjuvant Chemotherapy Switch in Borderline Resectable/Locally Advanced Pancreatic Cancer.Alva-Ruiz, R., Yohanathan, L., Yonkus, JA., et al.[2022]

References

Neoadjuvant Chemotherapy Enhances Local Postoperative Histopathological Tumour Stage in Borderline Resectable Pancreatic Cancer - A Matched-Pair Analysis. [2023]
No survival benefit with suboptimal CA19-9 response: defining effective neoadjuvant chemotherapy in resectable or borderline resectable pancreatic cancer. [2023]
Neoadjuvant Chemotherapy Switch in Borderline Resectable/Locally Advanced Pancreatic Cancer. [2022]
Effect and limitation of neoadjuvant chemotherapy for pancreatic ductal adenocarcinoma: consideration from a new perspective. [2021]
Neoadjuvant chemotherapy for primary resectable pancreatic cancer: a systematic review and meta-analysis. [2021]
Impact of adverse events of adjuvant and neoadjuvant chemotherapies on outcomes of patients with pancreatic ductal adenocarcinoma. [2023]
Pilot study of neoadjuvant chemotherapy with gemcitabine and oral S-1 for resectable pancreatic cancer. [2022]
Clinical Efficacy of Neoadjuvant Chemotherapy with Gemcitabine plus S-1 for Resectable Pancreatic Ductal Adenocarcinoma Compared with Upfront Surgery. [2023]