Feasibility Study on Using a New Radiation Device for Treating Borderline Resectable Pancreatic Cancer

Sponsor: CivaTech Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02843945

Provider View

This study is testing a new radiation device called CivaSheet to see if it can help control pancreatic cancer more effectively during surgery, especially when the cancer is close to the edges of the tissue being removed.

Patient Parameters

Program Overview

The study aims to find out if a new radiation device, CivaSheet, can safely and effectively help control pancreatic cancer during surgery. This device uses a special type of radiation to target cancer cells while protecting nearby healthy tissues. The study will measure how well the device works in delivering the right amount of radiation to the cancerous area, especially when the cancer is close to the edges of the tissue being removed.

Description

This study is exploring a new radiation treatment for pancreatic cancer using a device called CivaSheet. The device delivers radiation in one direction, which helps focus the treatment on cancer cells while minimizing exposure to nearby healthy tissues. The study will assess the safety and effectiveness of this approach, particularly in cases where the cancer is close to the edges of the tissue being removed during surgery. The main goal is to determine the right dose of radiation and how well it controls the cancer locally. This could potentially benefit patients by reducing the risk of cancer returning after surgery.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Not pregnant or breastfeeding.
  • Able to undergo anesthesia.
  • Scheduled for a Whipple procedure or distal pancreatectomy.
  • No spread of cancer to other parts of the body.
  • Cancer is close to the edges of the tissue being removed.
  • No previous radiation therapy to the area for another cancer.
  • Diagnosed with borderline resectable or locally advanced pancreatic cancer.
  • Received chemotherapy and radiation before surgery (4-10 weeks prior).
  • Chemotherapy included drugs like Gemcitabine, nb-paclitaxel, or FOLFIRINOX.
  • Radiation was given as IMRT, 3DCRT, or SBRT with specific doses.

Exclusion Criteria

  • Not eligible for surgery.
  • Had another invasive cancer in the last 5 years, except certain skin cancers.
  • Candidate for a different treatment called IRE.
  • Tumors that have come back or were previously removed.
  • History of alcoholism or drug abuse.
  • Participating in other clinical trials.

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