A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- N… (NCT03076216) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.
United States9 participantsStarted 2017-08-01
Plain-language summary
To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements.
The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Histologically or cytologically proven adenocarcinoma of the pancreas.
âś“. Stage III unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumors (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
✓. Pancreatic target tumor diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading center.
âś“. 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 gemcitabine and nab-paclitaxel chemotherapy, or gemcitabine alone, (per standard of care (SoC) according to the approved prescribing schedule), within 14 days post enrollment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle.
âś“. Provide signed Informed Consent.
âś“. Willing and able to complete study procedures within the study timelines.
Exclusion criteria
âś•. Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading center.
âś•. More than one primary lesion.
âś•. Any prior radiotherapy or chemotherapy for pancreatic cancer.
What they're measuring
1
Safety / Tolerability of Device as determined by the number of treatment emergent adverse events (TEAEs) evaluated 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.
âś•. Pregnant or lactating.
âś•. In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
âś•. 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.
âś•. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).