Pancreatic AdenocarcinomaRadioFAPNCT06743386
Pilot Study of EUS-Guided Radiofrequency and FOLFIRINOX in Advanced Pancreatic Cancer (RadioFAP )
A study testing Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA) in people with Pancreatic Adenocarcinoma, run by French Society of Digestive Endoscopy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 1. Other types of non-ductal or solid pancreatic tumors, including endocrine tumors, acinar cell adenocarcinoma, cystadenocarcinoma, and malignant ampullary tumors.
- 2. 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).
- 5. Pre-existing neuropathy, Gilbert's disease, or known UGT1A128/28 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.
- 8. 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.
- 11. Contraindication to echo-endoscopy-guided cytopuncture (coagulation disorders or previously operated stomach).
- 12. Neutrophil count < 1500/mm³. 13. Platelet count < 70,000/mm³. 14. Patients are not effectively treated for neoplastic jaundice if present at diagnosis.
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- 15. Patient in an exclusion period or currently participating in another clinical research protocol.
- 16. 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.
- 18. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs).
About this study
Official title: Pilot Study Evaluating the Combination of Endoscopic Ultrasound-Guided Radiofrequency and FOLFIRINOX in Locally Advanced Pancreatic Cancer
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
- Being tested
- Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA)
- Keywords
- EUS-Guided Radiofrequency Ablation (RFA), Pancreatic Tumor Ablation, Minimally Invasive Tumor Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2, 6, 9, 12, and18 months
Secondary outcomes (6)
Progression-Free Survival:
The time interval between the date of enrollment in the study and the point at which the disease progresses
Measured: 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
Measured: 2, 6, 9, 12, and18 months
Impact of radiofrequency tumor ablation with FOLFIRINOX on quality of life
Assessed using the EORTC QLQ-C30 questionnaire
Measured: 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
Measured: 2, 6, 9, 12, and18 months
Pancreatic intratumoral radiofrequency technical success
Defined as successful EUS-RFA execution, including needle insertion and ablation feasibility
Measured: 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
Measured: 14 days before chemotherapy and at 2 and 4 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study startApr 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society of Digestive Endoscopy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc BARTHET, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743386
- Sponsor's protocol ID
- SFED-159
- Acronym
- RadioFAP
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Combination of Endoscopic Ultrasound-Guided Radiofrequency and FOLFIRINOX in Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06743386
- Acronym / sponsor ID
- RadioFAP / SFED-159
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- EUS-Guided Radiofrequency Ablation (RFA), Pancreatic Tumor Ablation, Minimally Invasive Tumor Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- French Society of Digestive EndoscopyUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-Guided Radiofrequency Ablation (RFA) | Experimental | Device: Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA)Therapeutic procedure that combines endoscopic ultrasound (EUS) with radiofrequency ablation technology according to the practices of the investigating center |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 1. Other types of non-ductal or solid pancreatic tumors, including endocrine tumors, acinar cell adenocarcinoma, cystadenocarcinoma, and malignant ampullary tumors.
- 2. 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).
- 5. Pre-existing neuropathy, Gilbert's disease, or known UGT1A128/28 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.
- 8. 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.
- 11. Contraindication to echo-endoscopy-guided cytopuncture (coagulation disorders or previously operated stomach).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA)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. | Device | EUS-Guided Radiofrequency Ablation (RFA) |
Primary outcome
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
6 secondary outcomes
Progression-Free Survival:
Time frame: 2, 6, 9, 12, and18 months
Impact of radiofrequency tumor ablation combined with FOLFIRINOX on overall survival
Time frame: 2, 6, 9, 12, and18 months
Impact of radiofrequency tumor ablation with FOLFIRINOX on quality of life
Time frame: 2, 6, 9, 12, and 18 months
Effect of radiofrequency ablation combined with FOLFIRINOX on secondary resectability
Time frame: 2, 6, 9, 12, and18 months
Pancreatic intratumoral radiofrequency technical success
Time frame: 14 days before chemotherapy and at 2 and 4 months post-treatment.
RFA tolerance
Time frame: 14 days before chemotherapy and at 2 and 4 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic procedure combines EUS-Guided Radiofrequency Ablation (RFA) in people with Pancreatic Adenocarcinoma, run by French Society of Digestive Endoscopy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.