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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109041
• Other study ID #: CT005
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: CivaTech Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Device:
• CivaSheet
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.

Locations

Country	Name	City	State
United States	East Carolina University, Brody School of Medicine	Greenville	North Carolina

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 & 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.	1.5 years