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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

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE September 6, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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 the Whipple procedure will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.
Change History Complete list of historical versions of study NCT03109041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Official Title  ICMJE Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreas Cancer
  • Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: CivaSheet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
11
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carra Castagnero 9193145515 ccastagnero@tabclinical.com
Contact: Kristy Perez, PhD 6789545744 kperez@civatechoncology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109041
Other Study ID Numbers  ICMJE CT005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CivaTech Oncology
Study Sponsor  ICMJE CivaTech Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CivaTech Oncology
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP