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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)
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.
Primary Objectives: Evaluate the structure preservation rate for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care. Secondary Objectives: Evaluate progression-free survival (PFS) for this patient population. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration). Evaluate site reported p16 data and correlate with outcome. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of orbit and skull base preservation. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. Exploratory Tobacco Use Objectives: To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events (both clinical and hematologic) and dose modifications). To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit. NOTE: Tobacco Use objectives described above are ancillary for the Tobacco Use Assessment project approved by NCI. A combined analysis of the data from the selected ECOG-ACRIN trials is planned. Data collected from the tobacco use assessment in each parent study will not be analyzed and reported in the clinical study report.
Paraplatin (carboplatin); Taxotere (docetaxel); carboplatin (); cisplatin (); docetaxel ()