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

Launched by CIVATECH ONCOLOGY · Jul 21, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat borderline resectable pancreatic cancer, which is a type of cancer that can be challenging to remove completely through surgery. The researchers are looking at a special device called the CivaSheet, which is used during surgery to help control the cancer's growth. The goal is to see how effective this method is in patients who may have cancer cells close to the edges of the tissue that is removed.

To participate in this trial, patients need to be at least 18 years old, not pregnant or breastfeeding, and able to have anesthesia for surgery. They should be scheduled for a specific type of surgery called a Whipple procedure or distal pancreatectomy and must have received certain treatments before surgery. Patients who have had other major cancers or certain health issues may not be eligible. Those who join the study will help researchers understand how well this new treatment works and may contribute to developing better options for future patients with pancreatic cancer.

Gender

ALL

Eligibility criteria

• 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