RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Official Title

Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Quick Facts

Study Start:2017-05-31
Study Completion:2027-05-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02843945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Subject signed inform consent
  2. * Age \> 18 years
  3. * Not pregnant or breast feeding
  4. * Patient capable of undergoing anesthesia
  5. * Patient selected to undergo Whipple procedure or distal pancreatectomy
  6. * Patient does not have metastatic disease
  7. * Patients will have close margins
  8. * No prior radiation therapy to the region for separate cancer
  9. * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  10. * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  11. * Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  12. * Gemcitabine + nb-paclitaxel
  13. * FOLFIRINOX
  14. * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
  15. * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
  1. * Not surgical candidate
  2. * Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
  3. * An IRE candidate (IRE is Percutaneous irreversible electroporation)
  4. * Recurrent or previously resected tumors
  5. * Documented History of Alcoholism and or drug abuse
  6. * Participant in other clinical trials

Contacts and Locations

Study Contact

Kristy Perez
CONTACT
919-314-5515
clinical@civatechoncology.com
Kristy Perez, PhD
CONTACT
9193145515

Principal Investigator

Joshua Meyer, MD
PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center

Study Locations (Sites)

Rush University Cancer Center
Chicago, Illinois, 60612
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
University Medical Center LSU
New Orleans, Louisiana, 70112
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: CivaTech Oncology

  • Joshua Meyer, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-31
Study Completion Date2027-05-28

Study Record Updates

Study Start Date2017-05-31
Study Completion Date2027-05-28

Terms related to this study

Keywords Provided by Researchers

  • brachytherapy
  • CivaSheet
  • CivaTech
  • whipple
  • radiation
  • borderline resectable
  • locally advanced
  • Pd-103
  • intraoperative radiation

Additional Relevant MeSH Terms

  • Pancreatic Cancer