EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)
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|ClinicalTrials.gov Identifier: NCT02336672|
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma Non-resectable||Device: Cryothermal ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma|
|Actual Study Start Date :||November 11, 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
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.
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.
Device: Cryothermal ablation
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 Name: HybridTherm probe
- 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.
- Response to treatment [ Time Frame: At 2 and 4 months after the 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
- Evaluation of cell disruption / necrosis of the treated area [ Time Frame: At 2 and 4 months after the treatment ]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.
- Rate of resectability [ Time Frame: After 4 months pf treatment ]Evaluated by the number of resectable patients after four month of treatment
- R0 Resection Rate: [ Time Frame: After surgical resection ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336672
|Contact: Paolo Giorgio Arcidiacono, MD FASGE||+39 email@example.com|
|Ospedale San Raffaele Irccs||Recruiting|
|Milan, MI, Italy, 20132|
|Contact: Paolo Giorgio Arcidiacono, MD +39-02-26435607 firstname.lastname@example.org|
|Principal Investigator:||Paolo Giorgio Arcidiacono, MF FASGE||IRCCS San Raffaele|