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Recruiting NCT02843945

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

Phase I / Phase II Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Directional Brachytherapy Source Implant.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Detailed description

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit 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. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Interventions

  • Device Directional Brachytherapy Source Implant
    The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton 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

  • Safety of CivaSheet Radiation Treatement [Time frame: 1 Year]
Secondary outcome measures (4)
  • Efficacy of CivaSheet Radiation Treatment [Time frame: 1 Year]
  • Morbidity of patients following surgery and radiation [Time frame: 2 Year]
  • Post Operative Radiation Dosimetry Calculation [Time frame: 1 Month]
  • Length of Hospital Stay [Time frame: 1 Month]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Tampa General Hospital — Tampa
  • Rush University Cancer Center — Chicago
  • Advocate Christ Medical Center — Oak Lawn
  • University Medical Center LSU — New Orleans
  • Fox Chase Cancer Center — Philadelphia
  • Virginia Commonwealth University Massey Cancer Center — Richmond

Identifiers

NCT: NCT02843945 · CT004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗