Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06743386

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 1. 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.
  • Patient in an exclusion period or currently participating in another clinical research protocol.
  • 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).

Treatment and study plan

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.

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.

    Time frame: 2, 6, 9, 12, and18 months

    This rate will be defined as the ratio of satisfactory deliveries (without serious adverse events) to the total number of deliveries performed

Secondary outcomes

  1. Progression-Free Survival:

    Time frame: 2, 6, 9, 12, and18 months

    The time interval between the date of enrollment in the study and the point at which the disease progresses

  2. Impact of radiofrequency tumor ablation combined with FOLFIRINOX on overall survival

    Time frame: 2, 6, 9, 12, and18 months

    Measured from study enrollment to date of death, regardless of cause

  3. Impact of radiofrequency tumor ablation with FOLFIRINOX on quality of life

    Time frame: 2, 6, 9, 12, and 18 months

    Assessed using the EORTC QLQ-C30 questionnaire

  4. Effect of radiofrequency ablation combined with FOLFIRINOX on secondary resectability

    Time frame: 2, 6, 9, 12, and18 months

    Assessed through regular CT scans (RECIST 1.1) to determine if initially unresectable tumors become resectable after RFA treatment

  5. Pancreatic intratumoral radiofrequency technical success

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

    Defined as successful EUS-RFA execution, including needle insertion and ablation feasibility

  6. RFA tolerance

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

    Defined as the ratio of adverse events (AEs) to the total number of patients who underwent EUS-RFA

Sponsors and collaborators

Lead sponsor

French Society of Digestive Endoscopy

Other

Registry information

Official study title

Pilot Study Evaluating the Combination of Endoscopic Ultrasound-Guided Radiofrequency and FOLFIRINOX in Locally Advanced Pancreatic Cancer

Acronym: RadioFAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.