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

Sponsor

CivaTech Oncology (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02843945

Collaborator

(none)

Enrollment

Locations

Arm

90.1

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Device: Directional Brachytherapy Source Implant	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 31, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Cancer Center	Chicago	Illinois	United States	60612
2	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
3	University Medical Center LSU	New Orleans	Louisiana	United States	70112
4	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
5	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298