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

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.

Conditions

Pancreatic Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Cancer Center, Chicago, Illinois, United States, 60612

Oak Lawn

Advocate Christ Medical Center, Oak Lawn, Illinois, United States, 60453

New Orleans

University Medical Center LSU, New Orleans, Louisiana, United States, 70112

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111

Richmond

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States, 23298

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • Subject signed inform consent
  • * Age \> 18 years
  • * Not pregnant or breast feeding
  • * Patient capable of undergoing anesthesia
  • * Patient selected to undergo Whipple procedure or distal pancreatectomy
  • * Patient does not have metastatic disease
  • * Patients will have close margins
  • * No prior radiation therapy to the region for separate cancer
  • * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  • * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  • * Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  • * Gemcitabine + nb-paclitaxel
  • * FOLFIRINOX
  • * 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)
  • * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
  • * Not surgical candidate
  • * Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
  • * An IRE candidate (IRE is Percutaneous irreversible electroporation)
  • * Recurrent or previously resected tumors
  • * Documented History of Alcoholism and or drug abuse
  • * Participant in other clinical trials

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CivaTech Oncology,

Joshua Meyer, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2027-05-28