A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gem… (NCT03003078) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study of OncoSilâ„¢ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane
Australia50 participantsStarted 2017-03-27
Plain-language summary
To evaluate the safety of OncoSilâ„¢ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy regulatory requirements.
The clinical investigation will be conducted at approximately 15 sites in Australia, the United Kingdom and Europe (Belgium) involving 40 patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically proven adenocarcinoma of the pancreas.
✓. Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
✓. Pancreatic target tumour diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading centre.
✓. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
✓. Study participants ≥ 18 years of age at screening.
✓. To commence first-line standard FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapy (per standard of care according to the approved prescribing schedule), within 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle.
✓. Provide signed Informed Consent.
✓. Willing and able to complete study procedures within the study timelines.
Exclusion criteria
✕. Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading centre.
✕. More than one primary lesion.
✕. Any prior radiotherapy or chemotherapy for pancreatic cancer.
What they're measuring
1
Safety / Tolerability of Device according to CTCAE V4.0
Timeframe: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner
. Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit 1, whichever is longer.
✕. Pregnant or lactating.
✕. In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
✕. History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
✕. Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment).