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

Phase 1

Completed

• Conditions: Pancreas Cancer; Cancer

• Registration Number: NCT03109041
• Lead Sponsor: CivaTech Oncology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2017-09-06
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale	1.5 years	Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.

Trial Locations

Locations (1)

East Carolina University, Brody School of Medicine; 🇺🇸 Greenville, North Carolina, United States