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

CivaTech Oncology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Device: Directional Brachytherapy Source Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02843945

CT004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Directional Brachytherapy Source Implant

Experimental group

Description:

Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. 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.

Treatment:

Device: Directional Brachytherapy Source Implant