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Completed

NCT Number: NCT03109041

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

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.

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Key information

Conditions

Pancreas Cancer Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

East Carolina University, Brody School of Medicine

Greenville, North Carolina, 27834, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CivaSheet

Device

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 outcomes

  1. Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CivaTech Oncology

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Apr 11, 2017
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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