The outcomes of concurrent EUS-guided intra-tumour injection of P-32 microparticles (OncoSil; OncoSil Medical, Australia) with chemotherapy in locally advanced pancreatic carcinoma in the local population is uncertain. The aim of the current study is to assess efficacy and safety of the intervention in the local population. We hypothesis that the intervention is safe and useful for tumour downstaging.
This would be a cohort study including patients with locally advanced pancreatic cancer medically fit to receive chemotherapy. Eligible patients would receive gemcitabine (GNP; 28- day cycles). P-32 microparticles (OncoSil; OncoSil Medical) implantation will be planned at weeks 4-5. P-32 activity will be calculated from patients' tumor volume (TV) to deliver 100 Gy absorbed dose, with implantation assessment by EUS and Bremsstrahlung SPECT/CT imaging. The primary endpoint was safety and tolerability, graded using CTCAE v4.0. Response will be assessed using RECIST 1.1 with 8-weekly CT scans and FDG-PET scans at baseline and week 12. The outcome parameters include adverse events, response of the tumour, local progression free survival and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
All patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle.
Department of Surgery, Prince of Wales Hospital
Hong Kong, Hong Kong
Adverse events
Any untoward medical occurrence, unintended disease or injury, oruntoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device
Time frame: 30 day
Overall survival
Overall survival of the patient
Time frame: 5 years
Local Disease Control Rate
proportion of study participants whose local tumour response is stable disease (SD), partial response (PR), or complete response (CR)
Time frame: 16 week
Local Progression Free Survival
the time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death, whichever comes first.
Time frame: 6 months
Progression Free Survival
the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR))
Time frame: 5 years
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