A Phase II Clinical Trial of Endoscopic Surgery Followed by Chemotherapy and Proton Radiation Therapy to Treat Large Sinus and Nasal Cancers

Full Title

A Phase II, Single-Arm Trial Assessing Local Control of Near Total Endoscopic Resection Followed by Concurrent Chemotherapy and Proton Radiation in the Treatment of Unresectable Sinonasal Tumors

Purpose

The usual treatment for large tumors in the sinuses and nasal cavity is chemotherapy and radiation therapy. In this study, doctors are evaluating the use of endoscopic surgery (performed through tubes inserted through the nose) to remove as much cancer tissue as possible in patients with large sinus and nasal cancers.

Patients will then receive chemotherapy with the drug cisplatin, as well as proton radiation therapy. Proton therapy differs from conventional photon radiation therapy because the radiation beams do not penetrate as deeply into tissue, possibly resulting in fewer side effects. The sinus and nasal function of patients in this study will be examined after treatment to assess not only how effective the therapy is, but its effects on function and quality of life.

Eligibility

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

  • Patients must have a cancer of the sinuses or nasal cavity that is too large to remove completely with surgery.
  • Patients must be able to receive chemotherapy and to travel to a proton therapy facility.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Marc A. Cohen at 212-639-3769.

Protocol

17-442

Phase

II

Disease Status

Newly Diagnosed

Investigator