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Recruiting Phase 2 NCT03493425

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

Trial Parameters

Condition Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7
Sponsor ECOG-ACRIN Cancer Research Group
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 82
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-03-12
Completion 2029-03-31
Interventions
CarboplatinCisplatinDocetaxel

Brief Summary

This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.

Eligibility Criteria

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * General physical condition compatible with the proposed chemotherapy and surgery * Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: * Stages T3 and T4a disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection * The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neo-adjuvant chemotherapy for patients on Arm B * Resection of skull base will be deemed necessary according to skull base bone erosion by CT or marrow involvement by MRI is noted; for any disease abutting the skull base; or for ethmoid sinus or frontal sinus involvement * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement

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