Clinical trial NCT02336672: EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)
Official title: EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma Non-resectable
Keywords: Pancreatic adenocarcinoma
Cryothermoablation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: 6-months after therapy onset
Secondary outcomes:
measure: Response to treatment
timeFrame: At 2 and 4 months after the treatment
measure: Evaluation of cell disruption / necrosis of the treated area
timeFrame: At 2 and 4 months after the treatment
measure: Rate of resectability
timeFrame: After 4 months pf treatment
measure: R0 Resection Rate:
timeFrame: After surgical resection
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele Irccs
state: MI
Study officials:
affiliation: IRCCS San Raffaele
name: Paolo Giorgio Arcidiacono, MF FASGE
role: PRINCIPAL_INVESTIGATOR
References: