Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:May 31, 2017
End Date:July 2021
Contact:Carra Castagnero
Email:clinical@civatechoncology.com
Phone:919-314-5515

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Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Initial study to evaluate local control and the preferred method of attachment of the
CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor
removal.

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy
device that provides unidirectional radiation which utilizes active components
(Palladium-103) of standard devices in a novel configuration.This pilot study may benefit
pancreatic cancer patients by reducing the radiation dose to adjacent critical structures,
while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The
appropriate dose and local control rate will be recorded the primary endpoint in order to
provide an efficacy assessment.

Inclusion Criteria:

- • Subject signed inform consent

- Age > 18 years

- Not pregnant or breast feeding

- Patient capable of undergoing anesthesia

- Patient selected to undergo Whipple procedure or distal pancreatectomy

- Patient does not have metastatic disease

- Patients will have close margins

- No prior radiation therapy to the region for separate cancer

- Confirmed diagnosis of borderline resectable or locally advanced pancreatic
adenocarcinoma

- Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)

- Chemotherapy was administered for 2-6 cycles with any combination of the
following agents:

- Gemcitabine + nb-paclitaxel

- FOLFIRINOX

- Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or
SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)

- up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine,
or infusional 5-fluorouracil

Exclusion Criteria:

- Not surgical candidate

- Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin
cancer

- An IRE candidate (IRE is Percutaneous irreversible electroporation)

- Recurrent or previously resected tumors

- Documented History of Alcoholism and or drug abuse

- Participant in other clinical trials
We found this trial at
5
sites
Philadelphia, Pennsylvania 19111
Principal Investigator: Josh Meyer, MD
Phone: 215-728-3512
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: Emma Fields, MD
Phone: 804-628-2334
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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Richmond, VA
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Chicago, Illinois 60612
Principal Investigator: Dian Wang, MD
Phone: 312-563-2008
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Chicago, IL
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New Orleans, Louisiana 70112
Principal Investigator: Jennifer Gnerlich, MD
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Paul Crossan, MD
Phone: 708-684-4694
Advocate Christ Medical Center Advocate Health Care, named among the nation
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