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)
ECOG-ACRIN Cancer Research Group
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.
Description
PRIMARY OBJECTIVES: I. Evaluate the structure preservation rate for patients with locally advanced resectable nasal and paranasal sinus squamous cell carcinoma (NPNSCC) with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care. II. 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: I. Evaluate progression-free survival (PFS) for this patient population. II. Examine the rate of struc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugCarboplatin
Given IV
- DrugCisplatin
Given IV
- DrugDocetaxel
Given IV
- RadiationImage Guided Radiation Therapy
Undergo image guided IMRT
- RadiationIntensity-Modulated Radiation Therapy
Undergo image guided IMRT
- OtherLaboratory Biomarker Analysis
Correlative studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (140)
- University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- Mercy Hospital Fort SmithFort Smith, Arkansas
- UC San Diego Moores Cancer CenterLa Jolla, California
- Stanford Cancer Institute Palo AltoPalo Alto, California