Back to Trials
NCT02843945PHASE1, PHASE2Recruiting

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

CivaTech Oncology

Start Date

5/31/2017

Completion Date

10/30/2028

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Directional Brachytherapy Source Implant

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Pancreatic Cancer

Locations

Tampa General Hospital

Tampa, Florida 33612

United States

Rush University Cancer Center

Chicago, Illinois 60612

United States

Advocate Christ Medical Center

Oak Lawn, Illinois 60453

United States

University Medical Center LSU

New Orleans, Louisiana 70112

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia 23298

United States