To assess the safety and feasibility of percutaneous CT-or ultrasound-guided RNT using the Oncosil* device in patients with non-progressive LAPC after induction chemotherapy treatment.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and feasibility of percutaneous RNT using the Oncosil* device defined by
the percentage of complications CTCAE grade 3 or higher.
Secondary outcome
• Technical success, defined as adequate puncture of the tumour and injection
of the Oncosil* device, aiming at complete tumor ablation.
• Non-serious events, defined as events with a CTCAE grade <3.
• Duration of the overall procedure (defined as the total time in the radiology
suite).
• Overall survival: defined as the period of time between diagnosis and any
cause of death. Patients alive at last follow-up are censored.
• Progression-free survival: defined as the period of time between diagnosis
until progression in the original tumor location (disease progression defined
by the RECIST-criteria), new-onset lymph node-or distant organ involvement, as
discovered following complaints of the patient or on routine CT-scan
assessment.
• Difference in serum CA19-9 (area under the curve) during the first three
months post-RNT.
• Systemic immune response at several time points following treatment.
Background summary
Pancreatic ductal adenocarcinoma (i.e. pancreatic cancer) is one of the leading
causes of cancer-related deaths worldwide. For the 40% of patients who present
with non-metastatic locally advanced (unresectable) disease (i.e. LAPC), local
ablative treatment modalities are being investigated to improve outcome.
Internal-radiation therapy or radionuclide therapy (RNT) is one of these
treatment options, which uses a radioactive agent inserted directly into the
tumor to deliver a high-dose of internal radiation. Possible advantages of RNT
over conventional external-beam radiation therapy include a higher dose of
radiation to be delivered inside a tumor and sparing of the surrounding
structures, resulting in a higher local tumor control rate and reduced
morbidity. Promising outcomes of RNT for LAPC using the OncoSil* device are
reported. Generally, this treatment modality is injected into the pancreatic
tumor using endo-ultrasonography guidance (EUS). However, prospective series
assessing the safety and feasibility of percutaneous RNT with the OncoSil*
device using ultrasound or CT-guidance in LAPC are lacking.
Study objective
To assess the safety and feasibility of percutaneous CT-or ultrasound-guided
RNT using the Oncosil* device in patients with non-progressive LAPC after
induction chemotherapy treatment.
Study design
This is a prospective, single-arm, phase 1-2 feasibility study. This study
follows the Transparent Reporting of Evaluations with Nonrandomized Designs
(TREND) statement.
Intervention
Eligible patients will undergo percutaneous ultrasound or CT-guided OncoSil*
injection. The first five procedures will be performed under general
anaesthesia. The following five cases hereafter will be performed under
sedation. Based on the treating physician*s judgment, the last five cases will
be performed under sedation or local analgesia. After OncoSil* treatment,
patients will continue systemic chemotherapy and routine follow-up as is
standard in clinical practice (i.e. consisting of three-monthly
contrast-enhanced CT-scans and regular CA19-9 tumor marker assessment).
Study burden and risks
Currently, patients with LAPC are preferably treated with FOLFIRINOX or
gemcitabine-nab-paclitaxel chemotherapy with palliative intent. Achieving local
control with ablative therapies in stage III disease is expected to add 4-6
months to overall survival obtained with chemotherapy as determined by a recent
systematic review and retrospective study of our research group. Furthermore,
tumor load reduction may lead to pain reduction with improvement of quality of
life. In this study, percutaneous RNT will be offered to a group of patients
with LAPC. Early studies on LAPC treatment using OncoSil* combined with
standard of care chemotherapy suggest the procedure to be feasible with an
acceptable safety profile. Median overall survival, one-year survival and
surgical resection rate were all significantly higher compared to the state of
the art therapy.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria
as: arterial involvement >90* or venous involvement >270*.
- At least RECIST stable disease after a minimum two months of chemotherapy
according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
- WHO 0-2
* FOLFIRINOX for patients with WHO 0-1 performance status and
gemcitabine-nab-paclitaxel for patients with > 1-2performance status.
Exclusion criteria
- Eligibility for resection
- Participation in other trials focussing on different ablative treatment
modalities such as radiofrequency ablation or irreversible electroporation for
LAPC
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- ASA 3/4
- Pregnancy
- Metastatic pancreatic cancer
- Epilepsy episode(s) in the past six months
- Longest tumor diameter >70 mm or total target tumor volume >110 ml
- Presence of multiple collateral vessels surrounding or adjacent to the target
tumor on radiologic imagining, prohibiting safe injection of the OncosilTM
device
- Presence (or significant risk) of varices near the target tumor on radiologic
imaging
- Recent clinically significant pancreatitis
- Previous administration of radiotherapy to the pancreas
- WHO > 2
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78596.000.22 |