A Phase II Study of a Permanently Implantable CivaSheet® in Patients with Lung Cancer

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Full Title

Phase II Study to Treat Lung Cancer with the Permanently Implantable LDR CivaSheet®

Purpose

Doctors usually prefer to treat non-small cell lung cancer (NSCLC) by removing a large part of the affected lung with an operation called a lobectomy. However, some patients are not able to have such a large part of their lung safely removed. Instead, the surgeon may remove only a smaller portion of the lung (sub-lobar resection). After such an operation, there is a chance that the cancer may come back in the same area. Radiation treatment to that area may reduce the chance of the cancer coming back, but can also expose other organs (such as the heart and esophagus) to radiation damage.

In this study, researchers are assessing the use of an implantable radioactive sheet called CivaSheet® in patients having sub-lobar resection for NSCLC. This form of radiation therapy can deliver radiation to a much smaller area and avoid exposing other organs to potential radiation damage. Researchers in this study want to find out how well the CivaSheet can prevent NSCLC growth after surgery.

The CivaSheet is a layer of small flat ¿buttons¿ placed on a sheet of film that can be cut and shaped in the operating room to fit the area of the lung where the tumor was removed. Each button contains a substance that gives off radiation. A layer of gold foil on one side of each button acts as a shield to prevent the radiation from being transmitted in that direction, which protects the tissues and organs that are not intended to receive radiation treatment. After the CivaSheet has been implanted, the patient’s body will slowly break it down over about 6 months until it is fully absorbed.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I or II NSCLC and be planning to have a sub-lobar resection.
  • Patients may not have previously received radiation therapy to the lungs.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Abraham Wu at 212-639-5257.

Protocol

20-088

Phase

II

Investigator

Co-Investigators