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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: Directional Brachytherapy Source Implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kristy Perez, PhD; Phone Number: 9193145515
• Study Contact Backup: Name: Kristy Perez; Phone Number: 919-314-5515; Email: clinical@civatechoncology.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • RUSH University Cancer Center
      • Contact: Zachary Miller; Phone Number: 312-563-2008; Email: Zachary_Miller@Rush.edu
      • Principal Investigator: Dian Wang, MD
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center
      • Contact: Colleen Valenti, OCN; Phone Number: 708-684-4694; Email: colleen.valenti@advocatehealth.com
      • Principal Investigator: Paul Crossan, MD
      • Sub-Investigator: Marc Mesleh, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Completed
      • University Medical Center LSU
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Not yet recruiting
      • Fox Chase Cancer Center
      • Contact: Andrew Novak; Phone Number: 215-728-3512; Email: Andrew.Novak@fccc.edu
      • Principal Investigator: Josh Meyer, MD
      • Sub-Investigator: Sanjay Reddy, MD
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University Massey Cancer Center
      • Contact: Daeryl Williamson; Phone Number: 804-628-2334; Email: johnsondl4@vcu.edu
      • Principal Investigator: Emma Fields, MD
      • Sub-Investigator: Brian Kaplan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Directional Brachytherapy Source Implant; Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.

Device: Directional Brachytherapy Source Implant; The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of CivaSheet Radiation Treatement	Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of CivaSheet Radiation Treatment	Patients will be monitored for one year to determine the local cancer recurrence rate	1 Year
Morbidity of patients following surgery and radiation	2 year survival rates for patients post surgery and CivaSheet radiation treatment	2 Year
Post Operative Radiation Dosimetry Calculation	Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory	1 Month
Length of Hospital Stay	Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.	1 Month

Collaborators and Investigators

• Sponsor: CivaTech Oncology
• Investigators: Principal Investigator: Joshua Meyer, MD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimated): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: radiation; brachytherapy; borderline resectable; locally advanced; CivaSheet; intraoperative radiation; Pd-103; whipple; CivaTech
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CT004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No