The objective of this study is to compare two IRE protocols for the treatment of LAPC that are currently being used in clinical treatment, to allow for the determination (based on survival and co-morbidity) of the optimal treatment protocol for IRE…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of CT-guided IRE. Primary outcomes after treatment are adverse
events and serious adverse events (defined as CTCAE grade >=3 complications),
which should not exceed 60%. Mortality should be below 5%.
Secondary outcome
Secondary endpoints are thermal injury, treatment duration, overall survival,
progression-free survival, difference in serum CA19-9 (area under the curve)
during the first 3 months post-IRE, temperature measurements in the treated
region during IRE procedure, extent of the ablation zone and treatment efficacy
on cross-sectional imaging (CT) 6 and 12 weeks after the procedure,
post-intervention serum levels of amylase, lipase, glucose and transaminases,
pain score (VAS) and analgesics use during the first three months post-IRE,
systemic inflammatory response and continuation of chemotherapy following IRE.
Background summary
Pancreatic carcinoma is the fifth leading cause of canceer related deaths in
the Netherlands. Approximately 40% of patients present with so called locally
advanced pancreatic carcinoma (LAPC). Currently, the gold standard (and only
curative treatment option) is surgical resection. However, patients with LAPC
are commonly not eligible for curative resection due to involvement of the
tumour with vital structures (e.g. blood vessels). Systemic therapy
(chemotherapy) is then indicated. This patient category has a dismal prognosis
(5-year survival rate 5-10%). Therefore local ablative treatment modalities
have recently gained interest. Irreversible electroporation (IRE) is one of
these new treatment modalities. Tumor destruction through IRE is realized with
the use of multiple electrodes applying ultra-short, but strong electrical
pulses. The main issue of IRE, however, is that the mechanism of work has not
clearly been defined. Therefore optimization (standardization) of treatment has
not been realized yet. It is due to this reason that many different clinics
performing IRE use varying treatment protocols, which are hardly supported by
evidence.
Study objective
The objective of this study is to compare two IRE protocols for the treatment
of LAPC that are currently being used in clinical treatment, to allow for the
determination (based on survival and co-morbidity) of the optimal treatment
protocol for IRE in LAPC in addition to treatment with chemotherapy.
Study design
This is a prospective, 2-arm, randomized feasibility study.
Intervention
Patients with pathology proven LAPC and stable disease after 2 months of
chemotherapy (FOLFIRINOX) will be randomized for either CT-guided IRE, with
either the Miami settings ), or the Louisville settings. IRE will be performed
under general anaesthesia with complete muscle relaxation. Follow-up imaging of
patients will be performed according to standard care. Serum levels of CA19-9
will be evaluated one day prior to IRE treatment, the day of hospital discharge
(generally 4-5 days following treatment) and 1, 3, 6, 12 and 24 months
thereafter. After IRE, patients will receive chemotherapy following the normal
treatment schedule.
Study burden and risks
Currently, patients with LAPC are treated with palliative intent with
chemotherapy. Achieving local control with local tumour ablative therapies in
stage III disease is expected to add 6 months to overall survival obtained with
chemotherapy. Furthermore, tumour load reduction may lead to pain reduction
with improvement of quality of life. In this study, CT-guided percutaneous IRE
ablation will be offered to the group of patients with unresectable,
non-disseminated disease. Early research performing IRE in pancreas has proven
the procedural safety and peri-procedural burden to be comparable with
conventional ablative therapies. Post IRE follow-up will not differ from
routine follow up in these patients.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years
- LAPC (either primary or tumour recurrence following resection)
- At least RECIST stable disease after 2 months of chemotherapy with FOLFIRINOX
- Capable of providing written and oral informed consent
- Candidate for IRE, maximum diameter LAPC 5cm
Exclusion criteria
- Participation in PELICAN trial focussing on radiofrequency ablation for LAPC
- Eligibility for resection
- Bleeding disorders which can not be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- WHO 2/3 or ASA 3/4
- ICD/pacemaker
- Both partial stenosis of the portal vein and hepatic artery of >50%
- Pregnancy
- Metastatic pancreatic cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59644.018.17 |
| OMON | NL-OMON29184 |