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

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ClinicalTrials.gov Identifier: NCT03109041
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Cancer Device: CivaSheet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Directional Brachytherapy Source Implant
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.
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109041


Contacts
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Contact: Carra Castagnero 9193145515 ccastagnero@tabclinical.com
Contact: Kristy Perez, PhD 6789545744 kperez@civatechoncology.com

Locations
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United States, North Carolina
East Carolina University, Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27834
Contact: Renee Coghill    252-744-5723    COGHILLL@ECU.EDU   
Contact: Amanda Wetherington    252-744-5723      
Principal Investigator: Emmanuel Zervos         
Sub-Investigator: Andrew Ju         
Sponsors and Collaborators
CivaTech Oncology

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Responsible Party: CivaTech Oncology
ClinicalTrials.gov Identifier: NCT03109041     History of Changes
Other Study ID Numbers: CT005
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CivaTech Oncology:
Whipple
brachytherapy
CivaSheet
CivaTech Oncology
radiation
intraoperative radiation
IORT
resectable pancreatic cancer
Pd-103
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases