Pancreatic adenocarcinoma (PDAC) constitutes 90% of pancreatic tumors and is projected to become the second leading cause of cancer-related mortality in Europe by 2030. In France, its incidence doubled in men and tripled in women between 1982 and 2012. PDAC remains the digestive cancer with the poorest prognosis, with a five-year overall survival rate below 10% across all stages. Only surgical management with R0 resection (surgical margins free of cancer cells) offers a chance for cure or prolonged survival. However, surgery is feasible in only 15% of patients, as the disease is typically diagnosed at a late stage-locally advanced in 35% of cases or metastatic in 50%. Chemotherapy, specifically FOLFIRINOX, is the standard treatment for advanced cases, but resistance to chemotherapy poses a significant challenge. A key contributor to this resistance is the tumor stroma, which constitutes most of the tumor mass. This fibrous tissue acts as a mechanical barrier, restricting blood flow and potentially limiting the delivery of chemotherapy to cancer cells. The development of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has shown promise in treating pancreatic neuroendocrine tumors (pNETs) and pancreatic cystic neoplasms, sparking interest in its potential for PDAC. Preliminary studies demonstrate the feasibility of radiofrequency in PDAC, showing increased blood flow around treated sites. Combining systemic chemotherapy with radiofrequency may enhance drug diffusion and improve treatment efficacy. Additionally, tumor thermoablation could stimulate an immune response, as observed in experimental and clinical research. This study aims to evaluate the feasibility of tumor destruction via radiofrequency ablation combined with FOLFIRINOX in improving progression-free survival for patients with PDAC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
It will be performed under general anesthesia with intubation, using a sectorial probe echoendoscope to target pancreatic tumors. Prophylactic measures, including intrarectal Diclofenac and antibiotics, are used to prevent complications. A high-frequency monopolar electrode needle is inserted into the lesion under ultrasound guidance, avoiding critical structures like pancreatic and biliary ducts. Energy is delivered until specific safety parameters are met, with multiple applications to maximize tumor coverage. RFA sessions are scheduled before, midway, and after chemotherapy cycles, and progress is monitored with routine imaging. Post-procedure care includes fasting, pain management, and standard blood tests. Patients are typically discharged the day after the procedure if no complications occur. Further treatment plans, including continuation or modification of chemotherapy and RFA, are determined based on disease progression observed in follow-up scans.
The success rate of tumor destruction achieved using radiofrequency ablation (RFA) with a radiofrequency needle guided by endoscopic ultrasound (EUS), in combination with chemotherapy.
This rate will be defined as the ratio of satisfactory deliveries (without serious adverse events) to the total number of deliveries performed
Time frame: 2, 6, 9, 12, and18 months
Progression-Free Survival:
The time interval between the date of enrollment in the study and the point at which the disease progresses
Time frame: 2, 6, 9, 12, and18 months
Impact of radiofrequency tumor ablation combined with FOLFIRINOX on overall survival
Measured from study enrollment to date of death, regardless of cause
Time frame: 2, 6, 9, 12, and18 months
Impact of radiofrequency tumor ablation with FOLFIRINOX on quality of life
Assessed using the EORTC QLQ-C30 questionnaire
Time frame: 2, 6, 9, 12, and 18 months
Effect of radiofrequency ablation combined with FOLFIRINOX on secondary resectability
Assessed through regular CT scans (RECIST 1.1) to determine if initially unresectable tumors become resectable after RFA treatment
Time frame: 2, 6, 9, 12, and18 months
Pancreatic intratumoral radiofrequency technical success
Defined as successful EUS-RFA execution, including needle insertion and ablation feasibility
Time frame: 14 days before chemotherapy and at 2 and 4 months post-treatment.
RFA tolerance
Defined as the ratio of adverse events (AEs) to the total number of patients who underwent EUS-RFA
Time frame: 14 days before chemotherapy and at 2 and 4 months post-treatment.
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