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AzTrials

Locally Advanced Pancreatic CancerPhase 2RFA of LAPCNCT01628458

Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

A Phase 2 study testing radiofrequency ablation (RFA) in people with Locally Advanced Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Locally Advanced Pancreatic Cancer
What is being tested?
radiofrequency ablation (RFA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteNetherlands
Study dates
Sep 2012to Nov 2014
Phase
Phase 2
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

  • Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
  • Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
  • Fully informed written consent given

Who cannot join

  • Patients younger than 18 years
  • Pregnancy
  • Patients with distant metastases
  • Portal vein thrombosis seen on CT preoperatively

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Read the detailed description

Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Being tested
radiofrequency ablation (RFA)
Keywords
Pancreatic cancer, locally advanced, irresectable, Radiofrequency, RFA
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • radiofrequency ablation (RFA)Procedure or surgery

    Also called CELON Power System, CE mark 0197

    RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.

Study groups in NCT01628458
Study groupRoleWhat they receive
radiofrequency ablationExperimentalNot described
Receives: Procedure: radiofrequency ablation (RFA)

What is being measured

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

  1. Safety

    The safety will be specified as the percentage of patients with complications directly related to RFA and the routinely performed double-bypass procedure, requiring re-intervention (i.e. endoscopy, radiology, or surgery). This is also known as a complication of grade III or higher in the Clavien-Dindo classification (internationally accepted classification for surgical complications). Moreover all in-hospital complications or complications developed within 30 days after the RFA procedure will be evaluated according to the Clavien-Dindo classification.

    Measured: Within 30 days after the RFA procedure

Secondary outcomes (6)

  1. survival

    Measured: 2 years after RFA procedure

  2. VAS pain score

    Measured: 3 months

  3. length hospital stay

    Measured: 3 months

  4. progression free survival

    Measured: 2 years after RFA procedure

  5. CA19-9 response

    Measured: 2 years after RFA procedure

  6. Chemotherapy

    Type, frequency, dosage and duration of chemotherapy will be registered.

    Measured: 2 years

Timeline

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

  1. First posted26 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2014
  4. Study completionNov 2014

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628458
Sponsor's protocol ID
12-018
Acronym
RFA of LAPC
Status last verified
Jan 2015
First submitted
20 Jun 2012
Last updated
2 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Cantore M, Girelli R, Mambrini A, Frigerio I, Boz G, Salvia R, Giardino A, Orlandi M, Auriemma A, Bassi C. Combined modality treatment for patients with locally advanced pancreatic adenocarcinoma. Br J Surg. 2012 Aug;99(8):1083-8. doi: 10.1002/bjs.8789. Epub 2012 May 30.

    PubMed 22648697

  • Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.

    PubMed 20069610

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiofrequency ablation (RFA) in people with Locally Advanced Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.

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 3 inclusion and 4 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 2 Feb 2015. 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 Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

Safety (time frame: Within 30 days after the RFA procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01628458, which also lists 2 linked publications.

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 2 Feb 2015.

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