Nose and Sinus Cancer
EA3163
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
STATUS: Closed to Accrual
This 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. Chemotherapy drugs, 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.
- Patients must be >= 18 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have a general physical condition compatible with the proposed chemotherapy and surgery
- Patients must have stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some patients 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
- Patients 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: 1. Invasion of orbital apex without involvement of the cavernous sinus 2. Dura invasion depending on extent of involvement and if total resection is deemed feasible. 3. Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible. 4. Nasopharynx invasion if very limited 5. 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. 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 neoadjuvant chemotherapy for patients on Arm B using the score sheet provided at the end of the protocol. * Resection of skull base will be deemed necessary according to skull base bone erosion by computed tomography (CT) or marrow involvement by magnetic resonance imaging (MRI) is noted; for any disease abutting the skull base * 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 randomization, or at any time while on study and during the 4 weeks preceding randomization
- 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 ineligible; 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 ineligbile
- 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 ineligbile
- Patients with a history of a different malignancy are ineligible, 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)
- For patients receiving cisplatin, creatinine clearance must be > 60 ml/min (=< 2 weeks prior to randomization); creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockcroft-Gault formula
- Total bilirubin within 1.5 x the upper limit of normal (ULN) (must be obtained =< 2 weeks prior to randomization)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)
- Alkaline phosphatase must be within 1.5 x ULN 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
- Patient must not have current peripheral neuropathy > grade 2 at time of randomization
- Patient 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
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the chemotherapy and radiation being used; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy * All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achived menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) 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)
- Patient must not be expected conceive or father children by using an accepted and effective method(s) of contraception or by abstain from sexual intercourse for the duration of their participation in the study
- Patient must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to randomization
United States
AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact
AZ
Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: [email protected]
University of Arizona Cancer Center-North Campus
Contact: Site Public Contact
Email: [email protected]
University of Arizona Cancer Center-Orange Grove Campus
Contact: Site Public Contact
CA
Palo Alto
Stanford Cancer Institute Palo Alto
Contact: Site Public Contact
Email: [email protected]
VA Palo Alto Health Care System
Contact: Site Public Contact
CT
New Haven
Smilow Cancer Center/Yale-New Haven Hospital
Contact: Site Public Contact
Email: [email protected]
Yale University
Contact: Site Public Contact
Email: [email protected]
FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact
Tampa
Moffitt Cancer Center
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Email: [email protected]
Moffitt Cancer Center - McKinley Campus
Contact: Site Public Contact
Email: [email protected]
Moffitt Cancer Center-International Plaza
Contact: Site Public Contact
Email: [email protected]
GA
Atlanta
Emory Proton Therapy Center
Contact: Site Public Contact
Email: [email protected]
Emory University Hospital Midtown
Contact: Site Public Contact
Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact
IA
Des Moines
Broadlawns Medical Center
Contact: Site Public Contact
Iowa Lutheran Hospital
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Iowa Methodist Medical Center
Contact: Site Public Contact
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Contact: Site Public Contact
West Des Moines
Methodist West Hospital
Contact: Site Public Contact
ID
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: [email protected]
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: [email protected]
IL
Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact
Northwestern University
Contact: Site Public Contact
Email: [email protected]
Rush MD Anderson Cancer Center
Contact: Site Public Contact
Email: [email protected]
University of Illinois
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Evanston
NorthShore University HealthSystem-Evanston Hospital
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Glenview
NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park
NorthShore University HealthSystem-Highland Park Hospital
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Mount Vernon
SSM Health Good Samaritan
Contact: Site Public Contact
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: [email protected]
The Carle Foundation Hospital
Contact: Site Public Contact
Email: [email protected]
KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: [email protected]
Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: [email protected]
Olathe
The University of Kansas Cancer Center - Olathe
Contact: Site Public Contact
Email: [email protected]
Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: [email protected]
Topeka
University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact
Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: [email protected]
KY
Louisville
The James Graham Brown Cancer Center at University of Louisville
Contact: Site Public Contact
UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: [email protected]
MA
Boston
Massachusetts General Hospital Cancer Center
Contact: Site Public Contact
Tufts Medical Center
Contact: Site Public Contact
Email: [email protected]
MI
Ann Arbor
University of Michigan Rogel Cancer Center
Contact: Site Public Contact
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Contact: Site Public Contact
Email: [email protected]
Detroit
Henry Ford Hospital
Contact: Site Public Contact
Email: [email protected]
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: [email protected]
Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: [email protected]
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Contact: Site Public Contact
Email: [email protected]
West Bloomfield
Henry Ford West Bloomfield Hospital
Contact: Site Public Contact
Email: [email protected]
MN
MO
Ballwin
Mercy Oncology and Hematology - Clayton-Clarkson
Contact: Site Public Contact
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: [email protected]
Joplin
Freeman Health System
Contact: Site Public Contact
Email: [email protected]
Mercy Hospital Joplin
Contact: Site Public Contact
Email: [email protected]
Kansas City
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: [email protected]
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Contact: Site Public Contact
Email: [email protected]
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact
Phelps Health Delbert Day Cancer Institute
Contact: Site Public Contact
Email: [email protected]
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Mercy Hospital South
Contact: Site Public Contact
Email: [email protected]
Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: [email protected]
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: [email protected]
Washington University School of Medicine
Contact: Site Public Contact
Email: [email protected]
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: [email protected]
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
Mercy Hospital Springfield
Contact: Site Public Contact
MT
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: [email protected]
Great Falls Clinic
Contact: Site Public Contact
Email: [email protected]
NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]
ND
Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: [email protected]
Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: [email protected]
NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: [email protected]
NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact
Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact
Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact
NY
Bay Shore
Northwell Health Imbert Cancer Center
Contact: Site Public Contact
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: [email protected]
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: [email protected]
Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: [email protected]
Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact
New Hyde Park
Long Island Jewish Medical Center
Contact: Site Public Contact
New York
Lenox Hill Hospital
Contact: Site Public Contact
Manhattan Eye Ear and Throat Hospital
Contact: Site Public Contact
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Mount Sinai Chelsea
Contact: Site Public Contact
Email: [email protected]
Mount Sinai Hospital
Contact: Site Public Contact
Email: [email protected]
Mount Sinai Union Square
Contact: Site Public Contact
Email: [email protected]
Rochester
University of Rochester
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OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: [email protected]
West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: [email protected]
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
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Email: [email protected]
PA
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Contact: Site Public Contact
Harrisburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Contact: Site Public Contact
Email: [email protected]
Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Contact: Site Public Contact
Email: [email protected]
Moon Township
UPMC Hillman Cancer Center in Coraopolis
Contact: Site Public Contact
Email: [email protected]
New Castle
UPMC Jameson
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Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: [email protected]
Pittsburgh
UPMC Hillman Cancer Center
Contact: Site Public Contact
UPMC-Passavant Hospital
Contact: Site Public Contact
UPMC-Presbyterian Hospital
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UPMC-Shadyside Hospital
Contact: Site Public Contact
Washington
UPMC Washington Hospital Radiation Oncology
Contact: Site Public Contact
Email: [email protected]
York
UPMC Memorial
Contact: Site Public Contact
SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: [email protected]
Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: [email protected]
TX
Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: [email protected]
UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: [email protected]
Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: [email protected]
VA
VT
WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: [email protected]
Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: [email protected]
WY
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 structure preservation for the orbit (freedom from orbital exenteration). III. Evaluate site reported p16 data and correlate with outcome. IV. Determine the accuracy of baseline/post-chemotherapy magnetic resonance imaging (MRI) and/or fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation. V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. EXPLORATORY TOBACCO USE OBJECTIVES: I. 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). II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided intensity modulated radiation therapy (IMRT) once daily (QD) for 5 fractions per week for 30 fractions. Patients with positive margins/positive extracapsular spread (ECS) in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin intravenously (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. ARM B: 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 cycles 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 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. After completion of study treatment, patients are followed up every 3 months if < 2 years from study entry and then every 6 months if 2-5 years from study entry.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its National Clinical Trials Network.


