To test the first feasibility and safety of intratumoral 166-holmium microspheres implantation in pancreatic cancer in a controlled, open-surgery setting.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is to establish the feasibility of intratumoral implantation
of 166Ho-PLLA-MS by evaluating the average tumour absorbed dose in Gy
calculated on SPECT. Microsphere distribution, absorbed dose and non-target
absorbed dose are also analysed using MRI and CT. Additionally, safety,
expressed in Common Terminology Criteria for Adverse Events (CTCAE v4.0) events
grade >= 3 deemed possibly, probably or definitely related to the implantation
procedure or medical device implanted, is monitored. Tumor response is
evaluated according to the RECIST 1.1 guidelines at 3 months.
Secondary outcome
• Safety, expressed in Common Terminology Criteria for Adverse Events (CTCAE
v4.0) events grade >= 3 deemed possibly, probably or definitely related to the
implantation procedure or medical device implanted.
• To evaluate the average tumour absorbed dose in Gy calculated on MR images.
• To evaluate the average tumour absorbed dose in Gy quantified using CT images
• To evaluate the distribution of absorbed dose throughout the 3D target area
(dose coverage).
• To evaluate non-target dose deposition (within the pancreas and outside the
pancreas).
• To evaluate the implant efficiency.
• To evaluate tumour response according to RECIST 1.1 at 3 months.
• The implant experience using a questionnaire for the performing physician(s).
• To evaluate radiation safety aspects for operators.
Background summary
Pancreatic cancer holds one of the worst prognoses of all known malignancies.
When curative resection of the tumor is no longer possible due to local
advancement, only intensive palliative chemotherapy or best-supportive care
remains, and survival decreases drastically to just 3% after 5 years. Minimal
invasive intratumoral injection of beta-minus (β-) emitting 166-holmium
microspheres (micro brachytherapy) may be feasible for patients with pancreatic
cancer who are no longer eligible for surgical resection.
Study objective
To test the first feasibility and safety of intratumoral 166-holmium
microspheres implantation in pancreatic cancer in a controlled, open-surgery
setting.
Study design
This is a single centre, non-randomized, open label, feasibility study with a
medical device in 2 to 6 patients.
Intervention
Intratumoral injection of beta-minus (β-) emitting holmium-166 poly(L-lactic
acid) microspheres (166Ho-PLLA-MS, QuiremSpheres©) in a suspension of 0.9% NaCl
and 0.1% Pluronic (phosphate buffer).
Study burden and risks
Patients who are eligible for inclusion will need to undergo one additional
screening when compared to conventional work-up for surgical resection.
Patients need to undergo one additional CT scan which increases radiation dose;
however, this is negligible when compared with the absorbed dose of the
166-holmium microspheres. Patients have an increased risk of pancreatitis,
bleeding, fistula*s, or local infection. However, the mortality rate of 166Ho
microsphere implantation is expected to remain the same as that of a pancreas
resection, at 1%. Clear benefits are the fulfilment of a treatment wish when
resection is no longer possible and the contribution to development of new
therapies for pancreatic cancer in future patients. Although benefit cannot be
assured, depending on stage, adjuvant/palliative care, and patient
characteristics, benefits may include pain reduction, local tumor control,
tumor shrinkage, and down-staging.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Female or male aged 18 years and over.
2. Diagnosis of primary borderline resectable pancreatic cancer by Dutch
Pancreatic Cancer Group (DPCG) guidelines:
3. Patient is deemed eligible for surgical resection of the pancreatic cancer,
however, during open surgery a more advanced disease than initially anticipated
is found and resection is no longer feasible.
4. Life expectancy of 12 weeks or longer.
5. World Health Organisation (WHO) Performance status 0-1.
6. One or more measurable lesions of at least 10 mm in the longest diameter by
spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours
(RECIST) 1.1 criteria.
7. Negative pregnancy test for women of childbearing potential.
Exclusion criteria
1. Radiation therapy within the last 4 weeks before the start of study therapy.
2. Calcifications in the pancreas or tumour that are highly expected to
obstruct the needle tract
3. Any unresolved toxicity greater than National Cancer Institute (NCI), Common
Terminology Criteria for Adverse Events (CTCAE version 4.0) grade 2 from
previous anti-cancer therapy.
4. Serum bilirubin > 250 µmol/l
5. Leukocytes < 4.0 10^9/l and/or platelet count < 100 10^9/l.
6. Significant cardiac event (e.g. myocardial infarction, superior vena cava
(SVC) syndrome, New York Heart Association (NYHA) classification of heart
disease >=2 within 3 months before entry, or presence of cardiac disease that in
the opinion of the Investigator increases the risk of ventricular arrhythmia.
7. Patient is deemed ineligible for implantation of 166Ho by an expert panel
(surgeon, nuclear medicine physician and researcher) due to tumour anatomy or
nearby structures.
8. Pregnancy or breast feeding (women of child-bearing potential).
9. Patients suffering from psychic disorders that make a comprehensive
judgement impossible, such as psychosis, hallucinations and/or depression.
10. Patients who are declared incompetent.
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 | NL76311.091.20 |