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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843945
• Other study ID #: CT004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 31, 2017
• Est. completion date: May 28, 2027

Study information

• Verified date: May 2024
• Source: CivaTech Oncology
• Contact: Kristy Perez
• Phone: 919-314-5515
• Email: clinical[@]civatechoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 28, 2027
• Est. primary completion date: May 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Cancer Center	Chicago	Illinois
United States	University Medical Center LSU	New Orleans	Louisiana
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CivaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of CivaSheet Radiation Treatement	Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.	1 Year
Secondary	Efficacy of CivaSheet Radiation Treatment	Patients will be monitored for one year to determine the local cancer recurrence rate	1 Year
Secondary	Morbidity of patients following surgery and radiation	2 year survival rates for patients post surgery and CivaSheet radiation treatment	2 Year
Secondary	Post Operative Radiation Dosimetry Calculation	Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory	1 Month
Secondary	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