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

Phase 1

Recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT02843945
• Lead Sponsor: CivaTech Oncology

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Study Start: 2017-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-17
• Primary Completion: 2027-10-29
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of CivaSheet Radiation Treatement	1 Year	Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Rush University Cancer Center; 🇺🇸 Chicago, Illinois, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

University Medical Center LSU; 🇺🇸 New Orleans, Louisiana, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Commonwealth University Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States