Pancreatic Adenocarcinoma Non-resectableNCT02336672
EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)
A study testing Cryothermal ablation in people with Pancreatic Adenocarcinoma Non-resectable, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- Cryothermal ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2014to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological diagnosis
- patients with borderline resectable/locally advanced pancreatic adenocarcinoma;
- patients no previously treated with neoadjuvant treatments, irrespective of the regimen
- age >18 years; ≤ 80
- genders eligible for study: both
- patients who can express their consent
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- Karnofsky Performance status >70;
- Life expectancy >6 months.
- PLT>100000/mcl; INR<1.5.
- adequate renal function with a creatinine threshold
- adequate bone marrow function (WBC ≥3500)
Who cannot join
- pregnancy
- acute pancreatitis
- patients having distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency.
Read the detailed description
About 40% of patients with pancreatic cancer have no metastasis at the moment of diagnosis, but in 20% of patients surgery is not feasible due to vascular invasion or poor general conditions. These patients with stage III pancreatic cancer (locally advanced or borderline resectable) may benefit from neoadjuvant chemotherapy or chemoradiotherapy. The HybridTherm probe is a new, minimally invasive device that can be safely applied under EUS guidance to locally ablate the pancreatic tissue adding a local efficacy to the systemic activity offered by chemotherapy and could give these patients a bigger chance of survival. The present study is an interventional randomized controlled phase II/III trial (device), that assigns patients into two groups: patients receiving standard chemotherapy alone and those receiving chemotherapy plus EUS-guided HybridTherm ablation. The randomization is performed at the time of EUS diagnosis and staging.
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Being tested
- Cryothermal ablation
- Keywords
- Pancreatic adenocarcinoma, Cryothermoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryothermal ablationDevice
Also called HybridTherm probe
Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.
| Study group | Role | What they receive |
|---|---|---|
| Group A Chemotherapy | No intervention | Patients receiving chemotherapy alone. These patients start standard chemotherapy right after the oncologist's evaluation according to accepted Guidelines of the Italian Association of Medical Oncologists (AIOM). Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI. |
| Group B Chemotherapy + HybridTherm | Experimental | Patients receiving chemotherapy plus EUS-guided Cryothermal Ablation with HybridTherm probe. These patients are first treated by cryothermal ablation and one week after they start with chemotherapy. Cryothermal ablation can be performed up to three times, with interval of 4 +/- 1 weeks. Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI. Receives: Device: Cryothermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
To demonstrate the efficacy of the HybridTherm probe in the control of the tumour progression in terms of progression-free survival, measured at 6-month after ther-apy onset (PFS-6). PFS-6 takes in consideration the tumor growth in relation to the volume/size evaluated as a difference between the previous and the current examination. In practice, it is the time interval between the enrolment of the patient and the first radiological evidence of tumor progression.
For patients who were resected (R0 and R1) the PFS is the time until the first radio-logical evidence of tumor recurrence, regardless size.
For not resected patients the PFS is the time until the first radiological evidence of a growth of the lesion > 20% in comparison to the previous exam.
Measured: 6-months after therapy onset
Secondary outcomes (4)
Response to treatment
Evaluated by the radiological response to the treatment calculated on the differ-ences of radiological images (DW-MRI) before treatment onset and after two and four month of treatment
Measured: At 2 and 4 months after the treatment
Evaluation of cell disruption / necrosis of the treated area
Measured with the Apparent Diffusion Coefficient in the dw-MRI which will be per-formed at the time of patients' enrolment, after HTP treatment (Group B) and after two and four month of treatment.
Measured: At 2 and 4 months after the treatment
Rate of resectability
Evaluated by the number of resectable patients after four month of treatment
Measured: After 4 months pf treatment
R0 Resection Rate:
Evaluated by the number of R0 resections for those patients who were submitted to sur-gery (see Rate of resectability) on the basis of the pathologists finding
Measured: After surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start11 Nov 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
- Investigators
- Paolo Giorgio Arcidiacono, MF FASGE, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336672
- Sponsor's protocol ID
- HTP/2014
- Status last verified
- Sep 2023
- First submitted
- 16 Dec 2014
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02336672
- Acronym / sponsor ID
- HTP/2014
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Keywords
- Pancreatic adenocarcinoma, Cryothermoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency.
Detailed description
About 40% of patients with pancreatic cancer have no metastasis at the moment of diagnosis, but in 20% of patients surgery is not feasible due to vascular invasion or poor general conditions. These patients with stage III pancreatic cancer (locally advanced or borderline resectable) may benefit from neoadjuvant chemotherapy or chemoradiotherapy. The HybridTherm probe is a new, minimally invasive device that can be safely applied under EUS guidance to locally ablate the pancreatic tissue adding a local efficacy to the systemic activity offered by chemotherapy and could give these patients a bigger chance of survival. The present study is an interventional randomized controlled phase II/III trial (device), that assigns patients into two groups: patients receiving standard chemotherapy alone and those receiving chemotherapy plus EUS-guided HybridTherm ablation. The randomization is performed at the time of EUS diagnosis and staging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Chemotherapy | No intervention | –Patients receiving chemotherapy alone. These patients start standard chemotherapy right after the oncologist's evaluation according to accepted Guidelines of the Italian Association of Medical Oncologists (AIOM). Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI. |
| Group B Chemotherapy + HybridTherm | Experimental | Device: Cryothermal ablationPatients receiving chemotherapy plus EUS-guided Cryothermal Ablation with HybridTherm probe. These patients are first treated by cryothermal ablation and one week after they start with chemotherapy. Cryothermal ablation can be performed up to three times, with interval of 4 +/- 1 weeks. Restaging is performed 2, 4 and 6 months after chemotherapy onset, with MDCT scan and DW-MRI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- pathological diagnosis
- patients with borderline resectable/locally advanced pancreatic adenocarcinoma;
- patients no previously treated with neoadjuvant treatments, irrespective of the regimen
- age >18 years; ≤ 80
- genders eligible for study: both
Key exclusion criteria (3 listed)
- pregnancy
- acute pancreatitis
- patients having distant metastasis
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 |
|---|---|---|
| Cryothermal ablationAlso: HybridTherm probeProcedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization. | Device | Group B Chemotherapy + HybridTherm |
Primary outcome
Progression free survival
Time frame: 6-months after therapy onset
To demonstrate the efficacy of the HybridTherm probe in the control of the tumour progression in terms of progression-free survival, measured at 6-month after ther-apy onset (PFS-6). PFS-6 takes in consideration the tumor growth in relation to the volume/size evaluated as a difference between the previous and the current examination. In practice, it is the time interval between the enrolment of the patient and the first radiological evidence of tumor progression. For patients who were resected (R0 and R1) the PFS is the time until the first radio-logical evidence of tumor recurrence, regardless size. For not resected patients the PFS is the time until the first radiological evidence of a growth of the lesion > 20% in comparison to the previous exam.
4 secondary outcomes
Response to treatment
Time frame: At 2 and 4 months after the treatment
Evaluation of cell disruption / necrosis of the treated area
Time frame: At 2 and 4 months after the treatment
Rate of resectability
Time frame: After 4 months pf treatment
R0 Resection Rate:
Time frame: After surgical resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Paolo Giorgio Arcidiacono, MF FASGE principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryothermal ablation in people with Pancreatic Adenocarcinoma Non-resectable, run by IRCCS San Raffaele at 1 site in Italy.
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 11 inclusion and 3 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (time frame: 6-months after therapy onset). 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 28 Sep 2023.