- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336672
EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)
EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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MI
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Milan, MI, Italy, 20132
- Ospedale San Raffaele IRCCS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- pregnancy
- acute pancreatitis
- patients having distant metastasis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Group A Chemotherapy
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.
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Experimental: Group B Chemotherapy + HybridTherm
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 6-months after therapy onset
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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. |
6-months after therapy onset
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to treatment
Time Frame: At 2 and 4 months after the treatment
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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
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At 2 and 4 months after the treatment
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Evaluation of cell disruption / necrosis of the treated area
Time Frame: At 2 and 4 months after the treatment
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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.
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At 2 and 4 months after the treatment
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Rate of resectability
Time Frame: After 4 months pf treatment
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Evaluated by the number of resectable patients after four month of treatment
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After 4 months pf treatment
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R0 Resection Rate:
Time Frame: After surgical resection
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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
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After surgical resection
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Giorgio Arcidiacono, MF FASGE, IRCCS San Raffaele
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTP/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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