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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Directional Brachytherapy Source Implant

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush University Cancer CenterRecruiting
Advocate Christ Medical CenterRecruiting
University Medical Center LSU
Fox Chase Cancer Center
Virginia Commonwealth University Massey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Directional Brachytherapy Source Implant

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety of CivaSheet Radiation Treatement

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

Secondary Outcome Measures

Efficacy of CivaSheet Radiation Treatment

Patients will be monitored for one year to determine the local cancer recurrence rate

Morbidity of patients following surgery and radiation

2 year survival rates for patients post surgery and CivaSheet radiation treatment

Post Operative Radiation Dosimetry Calculation

Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory

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.

Full Information

NCT ID

NCT02843945

First Posted

June 16, 2016

Last Updated

September 7, 2023

Sponsor

CivaTech Oncology

1. Study Identification

Unique Protocol Identification Number

NCT02843945

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 31, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CivaTech Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Dose escalation Phase I followed by a feasibility trial in Phase II

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Directional Brachytherapy Source Implant

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Directional Brachytherapy Source Implant

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety of CivaSheet Radiation Treatement

Description

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

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Efficacy of CivaSheet Radiation Treatment

Description

Patients will be monitored for one year to determine the local cancer recurrence rate

Time Frame

1 Year

Title

Morbidity of patients following surgery and radiation

Description

2 year survival rates for patients post surgery and CivaSheet radiation treatment

Time Frame

2 Year

Title

Post Operative Radiation Dosimetry Calculation

Description

Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory

Time Frame

1 Month

Title

Length of Hospital Stay

Description

Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.

Time Frame

1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristy Perez

Phone

919-314-5515

clinical@civatechoncology.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kristy Perez, PhD

Phone

9193145515

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua Meyer, MD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zachary Miller

Phone

312-563-2008

Zachary_Miller@Rush.edu

First Name & Middle Initial & Last Name & Degree

Dian Wang, MD

Facility Name

Advocate Christ Medical Center

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Colleen Valenti, OCN

Phone

708-684-4694

colleen.valenti@advocatehealth.com

First Name & Middle Initial & Last Name & Degree

Paul Crossan, MD

First Name & Middle Initial & Last Name & Degree

Marc Mesleh, MD

Facility Name

University Medical Center LSU

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Individual Site Status

Completed

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Novak

Phone

215-728-3512

Andrew.Novak@fccc.edu

First Name & Middle Initial & Last Name & Degree

Josh Meyer, MD

First Name & Middle Initial & Last Name & Degree

Sanjay Reddy, MD

Facility Name

Virginia Commonwealth University Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daeryl Williamson

Phone

804-628-2334

johnsondl4@vcu.edu

First Name & Middle Initial & Last Name & Degree

Emma Fields, MD

First Name & Middle Initial & Last Name & Degree

Brian Kaplan, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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