Phase II Randomized Trial of Neoadjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of t3 and t4a (and Selected t4b) Nasal and Paranasal Sinus Squamous Cell Carcinoma

This research study examines cancer of the sinonasal area. People who have this cancer and choose not to participate in a research study are treated with surgery followed by radiation therapy.

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. It is also unclear if chemotherapy will cause side effects without any other benefit. Chemotherapy may also cause side effects that could impact the ability to complete surgery and radiation.

There are several FDA-approved chemotherapy drugs that are commonly used in this type of cancer and include Docetaxel, Cisplatin and Carboplatin, along with the radiation therapy. For 100 patients who receive the usual approach for this cancer (surgery and radiation therapy), 35 patients will be alive at 5 years. We do not know if chemotherapy will improve the chances of survival or will lead to a lower chance of resection of the eye or the skull bone.

The purpose of this research study is to compare any good and bad effects of using chemotherapy along with surgery and radiation therapy. The addition of chemotherapy to the usual surgery and radiation could shrink the cancer/prevent it from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the chemotherapy approach should improve preservation of the eye or skull bone and overall survival compared to the usual approach. It is also possible that chemotherapy will cause side effects without improving the chances of having the eye or skull bone preserved, and it could delay or compromise the ability to perform surgery and/or radiation.

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• Males/Females >18 years of age
• General physical condition compatible with the proposed chemotherapy and surgery
• Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some participants with T4b disease deemed resectable by the treating surgeon can be included provided they fulfill all other eligibility criteria without involvement of the cavernous sinus)
• Participants with T4b who have the following characteristics leading to a T4b definition but who in the opinion of the treating surgeon can have resectable disease can be included provided they fulfill all other eligibility criteria and provided they have one of the following presentations:
  • Invasion of orbital apex without involvement of the cavernous sinus
  • Dura invasion depending on extent of involvement and if total resection is deemed feasible
  • Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible
  • Nasopharynx invasion if very limited
  • Clivus invasion if very limited. (Surgeons are encouraged to consult with the protocol surgical chair for these particular cases)
• Stages T3 and T4a and selected T4b disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection
• Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
• Participants with a history of a different malignancy are excluded, unless the disease has not progressed for ≥ 2 years
• Additional eligibility information in protocol

• Participants may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding registration
• Participants with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and/or both platinum-based chemotherapy agents are excluded. Participant must be able to receive at least one of the two proposed chemotherapy regimens
• Participants with evidence of distant metastases or leptomeningeal disease (LMD) are excluded
• Participants with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded
• Pregnancy/breastfeeding
• Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03493425