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

NCT02843945 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: CT004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreatic Cancer

Keywords

brachytherapy; CivaSheet; CivaTech; whipple; radiation; borderline resectable; locally advanced; Pd-103; intraoperative radiation

Outcome Measures

Primary Outcomes (1)

• Safety of CivaSheet Radiation Treatement

  Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.

  1 Year

Secondary Outcomes (4)

• Efficacy of CivaSheet Radiation Treatment

  1 Year

• Morbidity of patients following surgery and radiation

  2 Year

• Post Operative Radiation Dosimetry Calculation

  1 Month

• Length of Hospital Stay

  1 Month

Study Arms (1)

Directional Brachytherapy Source Implant

EXPERIMENTAL

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

Interventions

Directional Brachytherapy Source Implant DEVICE

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.

Directional Brachytherapy Source Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CivaTech Oncology: lead

Study Sites (6)

Tampa General Hospital

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Rush University Cancer Center

Chicago, Illinois, 60612, United States

COMPLETED

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

RECRUITING

University Medical Center LSU

New Orleans, Louisiana, 70112, United States

COMPLETED

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

COMPLETED

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

COMPLETED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Joshua Meyer, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carra Castagnero

CONTACT

919-314-5515; ccastagnero@civatechoncology.com

Kristy Perez, PhD

CONTACT

9193145515; kperez@civatechoncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation Phase I followed by a feasibility trial in Phase II

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 26, 2016
• Study Start: May 31, 2017
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)