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

Trial ID: NCT02843945

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Pancreatic Cancer

Interventions

• Directional Brachytherapy Source Implant

Eligibility

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

Sponsor

CivaTech Oncology

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows