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
Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7
About this trial
This is an interventional treatment trial for Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7
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 of periorbital fat documented by MRI imaging
- Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization
- Patients may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding enrollment
- Patients 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; patient must be able to receive at least one of the two proposed chemotherapy regimens
- Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded
- Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
- Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded
- Patients with a history of a different malignancy are excluded, unless the disease has not progressed for >= 2 years
- Absolute neutrophil count (ANC) > 1500/mm^3 =< 2 weeks prior to randomization
- Hemoglobin (Hgb) > 8.0 g/dL =< 2 weeks prior to randomization
- Platelet count > 100,000/mm^3 =< 2 weeks prior to randomization
- Creatinine clearance of > 60 ml/min; creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula =< 2 weeks prior to randomization
- Total bilirubin within normal limits (must be obtained =< 2 weeks prior to randomization)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
- Alkaline phosphatase must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
- Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
- No current peripheral neuropathy > grade 2 at time of randomization
- Patients must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
- Patients must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to registration
Sites / Locations
- University of Arizona Cancer Center-Orange Grove CampusRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Mercy Hospital Fort SmithRecruiting
- UC San Diego Moores Cancer Center
- Stanford Cancer Institute Palo AltoRecruiting
- VA Palo Alto Health Care SystemRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- Emory Proton Therapy CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Alphonsus Medical Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Rush - Copley Medical CenterRecruiting
- Northwestern University
- Rush University Medical CenterRecruiting
- Carle on VermilionRecruiting
- Carle Physician Group-EffinghamRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Saint Anthony Regional HospitalRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Iowa Lutheran HospitalRecruiting
- Methodist West HospitalRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Massachusetts General Hospital Cancer Center
- University of Michigan Comprehensive Cancer CenterRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Allegiance HealthRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- Henry Ford Macomb Health Center - Shelby TownshipRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center at North Kansas City Hospital
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Kalispell Regional Medical CenterRecruiting
- Community Medical HospitalRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Northwell Health Imbert Cancer CenterRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Roswell Park Cancer InstituteRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Long Island Jewish Medical CenterRecruiting
- Lenox Hill HospitalRecruiting
- Mount Sinai HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma CityRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- UPMC Jameson
- Thomas Jefferson University HospitalRecruiting
- UPMC-Presbyterian HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern Clinical Center at Richardson/Plano
- Inova Schar Cancer InstituteRecruiting
- Inova Fairfax HospitalRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua CenterRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Clinic Stevens Point CenterRecruiting
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A (surgery, IMRT, cisplatin, carboplatin)
Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)
Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.