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

Primary Purpose

Pancreas Cancer, Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CivaSheet

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103

Eligibility Criteria

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

Inclusion Criteria:

Subject signed informed consent
Age >/= 18 years
Biopsy confirmed adenocarcinoma pancreatic cancer
Patient capable of undergoing anesthesia
Patient is a surgical candidate
Patient selected to undergo pancreatic cancer resection
Patient will have known or suspected close/positive surgical margin
Confirmed diagnosis of resectable pancreatic adenocarcinoma
Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle

Exclusion Criteria:

Pregnant or breast feeding
Patient has metastatic disease
Patient has had prior radiation therapy to the region for separate cancer
Patient has had prior chemotherapy
Any other invasive cancer in the past 5 years, except basal cell skin
Recurrent or previously resected tumors
Alcoholism/Drug abuse

Sites / Locations

East Carolina University, Brody School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Directional Brachytherapy Source Implant

Arm Description

Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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 & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale

Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.

Secondary Outcome Measures

Full Information

NCT ID

NCT03109041

First Posted

April 6, 2017

Last Updated

September 7, 2023

Sponsor

CivaTech Oncology

1. Study Identification

Unique Protocol Identification Number

NCT03109041

Brief Title

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

Official Title

Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 6, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

June 30, 2023 (Actual)

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

5. Study Description

Brief Summary

This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable 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.

6. Conditions and Keywords

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

Pancreas Cancer, Cancer

Keywords

Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Directional Brachytherapy Source Implant

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CivaSheet

Intervention Description

The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation 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 & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale

Description

Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.

Time Frame

1.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject signed informed consent Age >/= 18 years Biopsy confirmed adenocarcinoma pancreatic cancer Patient capable of undergoing anesthesia Patient is a surgical candidate Patient selected to undergo pancreatic cancer resection Patient will have known or suspected close/positive surgical margin Confirmed diagnosis of resectable pancreatic adenocarcinoma Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle Exclusion Criteria: Pregnant or breast feeding Patient has metastatic disease Patient has had prior radiation therapy to the region for separate cancer Patient has had prior chemotherapy Any other invasive cancer in the past 5 years, except basal cell skin Recurrent or previously resected tumors Alcoholism/Drug abuse

Facility Information:

Facility Name

East Carolina University, Brody School of Medicine

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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