Unresectable Pancreatic CancerCHEMOFIRE-2NCT04093141
Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer
A study testing IRE in people with Unresectable Pancreatic Cancer, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
Trial summary
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC). The aim of the study is to evaluate the efficacy of IRE in this patient group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Pancreatic Cancer
- What is being tested?
- IRE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2019to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas.
- Largest tumor diameter ≤4 cm in any plane.
- >18 years of age.
- Prior treatment with neoadjuvant chemotherapy for at least 2 months
- Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment.
- Non-progressive disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECiST 1.1) after neoadjuvant treatment.
- Patients must be able to give informed consent.
Who cannot join
- Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound).
- ASA score >3
- ECOG performance status >2
- Pregnancy.
- Atrial fibrillation.
- Implanted electronic device e.g. cardiac pacemakers or other electrostimulators.
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- Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE).
- Signs of severe disease of the bone marrow, kidney or liver during time of treatment. Treatment may be postponed if the disease state is reversible.
- Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
- Patient is referred from hospital outside of Denmark
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Rasmus Virenfeldt Flak, MD, +4597661181, rasmus.virenfeldt@rn.dk
Mogens Tornby Stender, Consultant Surgeon, PhD, +4597661761, mogens.stender@rn.dk
About this study
Official title: Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC).
The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.
Read the detailed description
Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).
After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.
IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.
In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).
- Conditions
- Unresectable Pancreatic Cancer
- Being tested
- IRE
- Keywords
- locally advances pancreatic cancer, irreversible electroporation, nanoknife, phase II, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IREProcedure or surgery
Also called irreversible electroporation
in situ irreversible electroporation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: IRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival proportion from 1) diagnosis and 2) IRE
Measured: 2 years after the last patient is enrolled
Secondary outcomes (11)
Median overall survival from 1) diagnosis and 2) IRE
Measured: 2 years after the last patient is enrolled
Progression free survival after IRE
Measured: 2 years after the last patient is enrolled
Median time to local progression after IRE
Measured: 2 years after the last patient is enrolled
Median time to dissemination after IRE
Measured: 2 years after the last patient is enrolled
90-day complication rate and severity (Clavien-Dindo)
Measured: 90 days after the last patient is enrolled
Resection rate
Measured: 2 years after the last patient is enrolled
Quality of life (EORTC QLQ C-30)
Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial we be calculated seperately.
Measured: Every 3 months for 2 years after the intervention
Perioperative pain perception (VAS)
Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).
Measured: Every week for 1 month after the intervention
Long term pain perception (m-BPI-SF)
Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).
Measured: Every 3 months for 2 years after the intervention
ECOG performance status
Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" perfomance status scale (range 0 - 5, low score is better)
Measured: Every 3 months for 2 years after the intervention
Nutritional status assessment (PG-SGA-SF)
Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37,low score is better).
Measured: Every 3 months for 2 years after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 May 2019
- Primary completionMay 2022 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Pancreatic CancerStudies 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
- Model description
- Patients in the study will be compared to data from clinical registry.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
- Investigators
- Ole Thorlacius-Ussing, Professor, DMSc, Principal investigator, Department of gastrointestinal surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093141
- Sponsor's protocol ID
- N-20190013
- Acronym
- CHEMOFIRE-2
- Status last verified
- Mar 2021
- First submitted
- 3 May 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
- ClinicalTrials.gov ID
- NCT04093141
- Acronym / sponsor ID
- CHEMOFIRE-2 / N-20190013
- Conditions
- Unresectable Pancreatic Cancer
- Keywords
- locally advances pancreatic cancer, irreversible electroporation, nanoknife, phase II, efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of SurgeryUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 17 Sep 2019 (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.
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC).
The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.
Detailed description
Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).
After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.
IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.
In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients in the study will be compared to data from clinical registry.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: IRE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas.
- Largest tumor diameter ≤4 cm in any plane.
- >18 years of age.
- Prior treatment with neoadjuvant chemotherapy for at least 2 months
- Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment.
Key exclusion criteria (10 listed)
- Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound).
- ASA score >3
- ECOG performance status >2
- Pregnancy.
- Atrial fibrillation.
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 |
|---|---|---|
| IREAlso: irreversible electroporationin situ irreversible electroporation | Procedure or surgery | Intervention |
Primary outcome
2-year survival proportion from 1) diagnosis and 2) IRE
Time frame: 2 years after the last patient is enrolled
11 secondary outcomes
Median overall survival from 1) diagnosis and 2) IRE
Time frame: 2 years after the last patient is enrolled
Progression free survival after IRE
Time frame: 2 years after the last patient is enrolled
Median time to local progression after IRE
Time frame: 2 years after the last patient is enrolled
Median time to dissemination after IRE
Time frame: 2 years after the last patient is enrolled
90-day complication rate and severity (Clavien-Dindo)
Time frame: 90 days after the last patient is enrolled
Resection rate
Time frame: 2 years after the last patient is enrolled
Quality of life (EORTC QLQ C-30)
Time frame: Every 3 months for 2 years after the intervention
Perioperative pain perception (VAS)
Time frame: Every week for 1 month after the intervention
Long term pain perception (m-BPI-SF)
Time frame: Every 3 months for 2 years after the intervention
ECOG performance status
Time frame: Every 3 months for 2 years after the intervention
Nutritional status assessment (PG-SGA-SF)
Time frame: Every 3 months for 2 years after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ole Thorlacius-Ussing, Professor, DMSc principal investigator
Department of gastrointestinal surgery, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE in people with Unresectable Pancreatic Cancer, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasmus Virenfeldt Flak, MD (+4597661181, rasmus.virenfeldt@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival proportion from 1) diagnosis and 2) IRE (time frame: 2 years after the last patient is enrolled). 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 1 Apr 2021.