Pancreatic cancer Pancreatic carcinoma
Conditions
Interventions
Intratumoral injection of beta-minus (&beta
-) 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).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 =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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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. | — |
Countries
Netherlands
Outcome results
None listed