A Phase II Study of Surgery and Radiation Therapy with or without Presurgical Chemotherapy in Patients with Nasal and Paranasal Sinus Cancers

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Full Title

EA3163 Phase II Randomized Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Post-operative Radiation Versus Surgery and Post-operative Radiation for organ preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC) (CIRB)

Purpose

People with nasal and paranasal sinus cancers typically have surgery followed by radiation therapy. However, surgery can result in the need to sacrifice the eye or skull bone. It is not clear if adding chemotherapy to surgery will reduce the chances of needing to remove the eye or skull bone. That is what researchers want to find out in this study.

Patients in this study will be randomly assigned to one of two groups. One group will receive chemotherapy before surgery (docetaxel with either cisplatin or carboplatin) followed by surgery and radiation therapy. The second group will receive the standard treatment of surgery followed by radiation therapy. Researchers will compare the safety and effectiveness of the two approaches. The chemotherapy drugs used in this study are given intravenously (by vein).

Eligibility

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

  • Patients must have operable stage III or IVA squamous cell carcinoma of the nasal or paranasal sinuses.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

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

Protocol

19-164

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators