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Pancreatic AdenocarcinomaPhase 3NCT03649035

Eus-guided Cryothermal Ablation in Stage III Pancreatic Adenocarcinoma

A Phase 3 study testing HTP treatment in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Pancreatic cancer represents the 11th most commonly diagnosed cancer in men and 9th in women, being the third leading cause of cancer-related death in the Western countries. Pancreatic cancer has a very poor prognosis and median overall survival is less than 5 months in population-based studies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HTP treatment
Type of treatment
Medical device
How many people
0 participants
Where
1 siteItaly
Study dates
12 Jul 2018to 31 Dec 2020
Phase
Phase 3
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

  • Only patients with pathologically proven, locally advanced, unresectable pancreatic adenocarcinoma will be selected.
  • The criteria for unresectability will be: encasement or thrombosis of one or more large vessels surrounding the pancreas (celiac axis, portal vein, and/or superior mesenteric artery and/or vein, and/or hepatic artery, except the splenic vessels); infiltration of the vessel wall or contact 180° for more than 2 cm length, with initial stricture of the vessel or alteration of the Doppler signal (each patient will undergo thoracic and abdominal-CT with contrast medium to check resectability and detect the absence of distant metastasis).
  • Esclusion criteria:
  • Patients with pancreatic tumors other than pancreatic adenocarcinoma (PDAC)
  • Patients with resectable, borderline resectable or metastatic PDAC

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

About this study

Official title: Use of the Eus-guided Cryothermal Ablation in the Multimodality Approach to Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma

Pancreatic cancer represents the 11th most commonly diagnosed cancer in men and 9th in women, being the third leading cause of cancer-related death in the Western countries. Pancreatic cancer has a very poor prognosis and median overall survival is less than 5 months in population-based studies. Approximately 80% of patients with pancreatic cancer present with unresectable disease, which is either due to locally advanced or metastatic disease. About 40% of patients have metastases at the time of diagnosis and in another 30 to 40 % of the patients tumour resection is not feasible because of vascular invasion, or poor general conditions. In resectable patients surgical resection with negative margins (R0) continues to be worldwide considered the only chance to cure, however, this standard treatment is usually reserved to a small number of patients. 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 resectable disease. Several phase I - II studies have shown the capability of chemotherapy alone or chemo radiotherapy based regimens to increase the resection rates of these patients and the related median overall survival.

Systemic chemotherapy followed by chemoRT or stereotattic body radiation therapy (SBRT) is an option for selected patients with unresectable disease and good PS who have not developed metastatic disease.

Read more

This sequence is especially recommended in cases in which it is highly unlikely that the patient will become resectable (ie, complete encasement of SMA/superior celiac artery). Due to the significant rate of toxicity of the radio therapy (RT) treatment alone or in adjunct to chemotherapy, other local treatments with the goal to downstage the primary tumour with less or no toxicity as compared to RT have been proposed.

Radiofrequency (RF) has been used with success in solid cancers like the hepatocellular carcinoma while cryoablation has been used for breast and renal cancers. RFA has been applied in few clinical trials in human pancreatic cancer either without any imaging guidance or just under intra-operatory ultrasound control during palliative open surgery.

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.

In a recent in-vivo study the feasibility of the HTP in patients with unresectable locally advanced pancreatic adenocarcinoma has been shown. HTP has been applied under EUS-guidance to patients who have been already treated by chemotherapy (two lines) and in many cases with the adjunct of RT.

Being tested
HTP treatment
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTP treatmentDevice

    Elegible patients will undergo HTP treatment, followed by standard of care Chemo therapy and SBRT protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with feasible EUS-guided Cryothermal Ablation

    The procedure will be defined as "feasible" if the placement of the probe inside the tumor will be successful and "not feasible" if it will not be possible to place the probe inside the lesion because of difficulties such as hardness of the tumor, stiffness of the GI wall, or interposition of vessels

    Measured: The day of procedure

Secondary outcomes (2)
  1. 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 therapy onset (PFS-6) by MRI. PFS-6 takes in consideration the tumour 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.

    Measured: 6 months after the procedure

  2. Number of participants with treatment-related adverse events

    Complications will be recorded and laboratory and radiologic follow-up will be performed to detect them.

    Measured: 30 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start12 Jul 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Why it stopped: Stopped for internal decisions

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Treatment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649035
Sponsor's protocol ID
HTP1
Status last verified
Mar 2021
First submitted
7 Aug 2018
Last updated
19 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HTP treatment in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Istituto Clinico Humanitas 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 5 inclusion and 0 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: withdrawn, as of the sponsor's last update on 19 Mar 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 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of participants with feasible EUS-guided Cryothermal Ablation (time frame: The day of procedure). 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 19 Mar 2021.

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