Clinical trial NCT02843945: Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: brachytherapy
CivaSheet
CivaTech
whipple
radiation
borderline resectable
locally advanced
Pd-103
intraoperative radiation
Lead sponsor: CivaTech Oncology
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation Phase I followed by a feasibility trial in Phase II
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Safety of CivaSheet Radiation Treatement
timeFrame: 1 Year
Secondary outcomes:
measure: Efficacy of CivaSheet Radiation Treatment
timeFrame: 1 Year
measure: Morbidity of patients following surgery and radiation
timeFrame: 2 Year
measure: Post Operative Radiation Dosimetry Calculation
timeFrame: 1 Month
measure: Length of Hospital Stay
timeFrame: 1 Month
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Cancer Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: New Orleans
country: United States
facility: University Medical Center LSU
state: Louisiana
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
Study officials:
affiliation: Fox Chase Cancer Center
name: Joshua Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: