Pilot Study of EUS-Guided Radiofrequency and FOLFIRINOX in Advanced Pancreatic Cancer (RadioFAP )

NCT06743386 | Not Yet Recruiting

• 1 other identifier: SFED-159
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

EUS-Guided Radiofrequency Ablation (RFA); Pancreatic Tumor Ablation; Minimally Invasive Tumor Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  2, 6, 9, 12, and18 months

Secondary Outcomes (6)

• Progression-Free Survival:

  2, 6, 9, 12, and18 months

• Impact of radiofrequency tumor ablation combined with FOLFIRINOX on overall survival

  2, 6, 9, 12, and18 months

• Impact of radiofrequency tumor ablation with FOLFIRINOX on quality of life

  2, 6, 9, 12, and 18 months

• Effect of radiofrequency ablation combined with FOLFIRINOX on secondary resectability

  2, 6, 9, 12, and18 months

• Pancreatic intratumoral radiofrequency technical success

  14 days before chemotherapy and at 2 and 4 months post-treatment.

Study Arms (1)

EUS-Guided Radiofrequency Ablation (RFA)

EXPERIMENTAL

Therapeutic procedure that combines endoscopic ultrasound (EUS) with radiofrequency ablation technology according to the practices of the investigating center

Device: Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA)

Interventions

Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA) DEVICE

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.

EUS-Guided Radiofrequency Ablation (RFA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• Patients with locally advanced, borderline resectable, or inoperable pancreatic adenocarcinoma, confirmed by histological or cytological tests and assessed through a multidisciplinary consultation.
• Patients without evidence of metastases.
• No prior anti-tumoral treatment.
• World Health Organization (WHO) performance status ≤ 1.
• Measurable tumor according to the RECIST v1.1 criteria: a tumor lesion with the largest diameter ≥ 20 mm using conventional imaging techniques or ≥ 10 mm using spiral CT scan.
• Patient who has provided written consent.
• Patient with no contraindications to general anesthesia.
• Pancreatic tumor accessible via endoscopic ultrasound.
• Patient enrolled in a social security program (beneficiary or dependent).

You may not qualify if:

• \. Other types of non-ductal or solid pancreatic tumors, including endocrine tumors, acinar cell adenocarcinoma, cystadenocarcinoma, and malignant ampullary tumors.
• \. Presence of metastases. 3. Contraindication to treatment with 5FU, oxaliplatin, or irinotecan. 4. Patients with a tumor that could benefit from neoadjuvant treatment with radiochemotherapy or chemotherapy alone for secondary resection (decision by a multidisciplinary committee).
• \. Pre-existing neuropathy, Gilbert's disease, or known UGT1A1\*28/\*28 genotype. 6. Chronic inflammatory bowel disease. 7. Other concurrent cancers, or a history of cancer within the last 5 years, except for in situ cervical cancer that has been treated or a properly treated basal cell carcinoma or squamous cell carcinoma.
• \. Hereditary intolerance to fructose. 9. Individuals deprived of liberty or under guardianship. 10. Inability to follow up with the study due to geographical, social, or psychological reasons.
• \. Contraindication to echo-endoscopy-guided cytopuncture (coagulation disorders or previously operated stomach).
• \. Neutrophil count \< 1500/mm³. 13. Platelet count \< 70,000/mm³. 14. Patients are not effectively treated for neoplastic jaundice if present at diagnosis.
• \. Patients are unable to understand or read the information/consent form. 17. Pregnant women or those wishing to become pregnant during the study period, or breastfeeding women.
• \. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs).

Sponsors & Collaborators

• French Society of Digestive Endoscopy: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Endocopy, Principal Investigator, Medical doctor

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03