Study on NovoTTF-200T(P) with Gemcitabine and Nab-Paclitaxel for Treating Resectable Pancreatic Cancer

Sponsor: Ashish Manne

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05624918

Provider View

This clinical trial is testing a new treatment approach for patients with pancreatic cancer that can be surgically removed. The study combines a device called NovoTTF-200T(P) with chemotherapy drugs gemcitabine and nab-paclitaxel to see if it helps control the cancer better before and after surgery.

Patient Parameters

Program Overview

This study is exploring a treatment for pancreatic cancer that can be surgically removed. Patients will receive three cycles of chemotherapy with gemcitabine and nab-paclitaxel, along with a device called NovoTTF-200T(P) that is worn daily. After these treatments, patients will have scans to check the cancer's status. If the cancer is stable or better, surgery will be performed to remove it. After surgery, patients may receive additional cycles of the same treatment. The study aims to see how well this combination works and what side effects it might have.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for sharing health information.
  • Must be male or a non-pregnant, non-breastfeeding female, aged 18 or older.
  • Must have a performance status of 70% or higher, indicating the ability to carry out daily activities.
  • Must have confirmed pancreatic cancer that can be surgically removed, based on specific medical imaging criteria.
  • Must not have received any prior treatment for pancreatic cancer.
  • Must have adequate organ function, as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after.
  • Men must agree to use effective birth control during the study and for three months after.
  • Must be able to understand and follow study procedures.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C must have controlled or cured infections.

Exclusion Criteria

  • Cannot have cancer that has spread to distant parts of the body.
  • Cannot have an electrical device implanted in the torso, like a pacemaker.
  • Cannot have significant heart disease or uncontrolled heart rhythm problems.
  • Cannot be allergic to medical adhesives or gels used in the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have another cancer that might interfere with the study.
  • Cannot have severe or uncontrolled medical conditions that pose safety risks.
  • Cannot have had another cancer unless it was treated and disease-free for two years.
  • Must be willing and able to follow study procedures.

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