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

CivaTech Oncology

Status and phase: Completed; Phase 1

Conditions: Pancreas Cancer; Cancer

Treatments: Device: CivaSheet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03109041

CT005

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Directional Brachytherapy Source Implant

Experimental group

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.

Treatment:

Device: CivaSheet