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
NCT ID: NCT03493425
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
82 participants
INTERVENTIONAL
2019-03-12
2029-03-31
Brief Summary
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Detailed Description
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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 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.
TERTIARY 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 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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (surgery, IMRT, cisplatin, carboplatin)
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.
Carboplatin
Given IV
Cisplatin
Given IV
Image Guided Radiation Therapy
Undergo image guided IMRT
Intensity-Modulated Radiation Therapy
Undergo image guided IMRT
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Therapeutic Conventional Surgery
Undergo standard of care surgery
Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)
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.
Carboplatin
Given IV
Cisplatin
Given IV
Docetaxel
Given IV
Image Guided Radiation Therapy
Undergo image guided IMRT
Intensity-Modulated Radiation Therapy
Undergo image guided IMRT
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Therapeutic Conventional Surgery
Undergo standard of care surgery
Interventions
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Carboplatin
Given IV
Cisplatin
Given IV
Docetaxel
Given IV
Image Guided Radiation Therapy
Undergo image guided IMRT
Intensity-Modulated Radiation Therapy
Undergo image guided IMRT
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Therapeutic Conventional Surgery
Undergo standard of care surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Nabil Saba
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory Proton Therapy Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Saint Anthony Regional Hospital
Carroll, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Olathe Health Cancer Center
Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Lenox Hill Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
UPMC Jameson
New Castle, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Facility Contacts
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References
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Adilbay D, Valero C, Fitzgerald C, Yuan A, Mimica X, Gupta P, Wong RJ, Shah JP, Patel SG, Ganly I, Cohen MA. Outcomes in surgical management of sinonasal malignancy-A single comprehensive cancer center experience. Head Neck. 2022 Apr;44(4):933-942. doi: 10.1002/hed.26989. Epub 2022 Jan 25.
Other Identifiers
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NCI-2017-01364
Identifier Type: REGISTRY
Identifier Source: secondary_id
EA3163
Identifier Type: OTHER
Identifier Source: secondary_id
EA3163
Identifier Type: OTHER
Identifier Source: secondary_id
EA3163
Identifier Type: -
Identifier Source: org_study_id