Back to Trials
NCT03493425PHASE2Recruiting

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

ECOG-ACRIN Cancer Research Group

Start Date

3/12/2019

Completion Date

3/31/2029

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.

Detailed 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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Docetaxel

RADIATION

Image Guided Radiation Therapy

RADIATION

Intensity-Modulated Radiation Therapy

OTHER

Laboratory Biomarker Analysis

OTHER

Questionnaire Administration

PROCEDURE

Therapeutic Conventional Surgery

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7

Locations

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona 85704

United States

Banner University Medical Center - Tucson

Tucson, Arizona 85719

United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona 85719

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas 72903

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California 94304

United States

VA Palo Alto Health Care System

Palo Alto, California 94304

United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut 06510

United States

Yale University

New Haven, Connecticut 06520

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida 33442

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida 33136

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida 33324

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida 33612

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory Proton Therapy Center

Atlanta, Georgia 30308

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho 83706

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho 83814

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho 83642

United States

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho 83686

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho 83854

United States

Rush - Copley Medical Center

Aurora, Illinois 60504

United States

Northwestern University

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Carle on Vermilion

Danville, Illinois 61832

United States

Carle Physician Group-Effingham

Effingham, Illinois 62401

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois 60201

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois 60026

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois 60035

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois 61938

United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois 62864

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

The Carle Foundation Hospital

Urbana, Illinois 61801

United States

Saint Anthony Regional Hospital

Carroll, Iowa 51401

United States

Iowa Methodist Medical Center

Des Moines, Iowa 50309

United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa 50309

United States

Broadlawns Medical Center

Des Moines, Iowa 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa 50316

United States

Methodist West Hospital

West Des Moines, Iowa 50266-7700

United States

Central Care Cancer Center - Garden City

Garden City, Kansas 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas 67530

United States

University of Kansas Cancer Center

Kansas City, Kansas 66160

United States

Lawrence Memorial Hospital

Lawrence, Kansas 66044

United States

Olathe Health Cancer Center

Olathe, Kansas 66061

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas 66210

United States

Ascension Via Christi - Pittsburg

Pittsburg, Kansas 66762

United States

Salina Regional Health Center

Salina, Kansas 67401

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas 66606

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas 66205

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky 40202

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts 02114

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan 48109

United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan 48183

United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan 48038

United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan 48126

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan 48334

United States

Allegiance Health

Jackson, Michigan 49201

United States

Henry Ford Medical Center-Columbus

Novi, Michigan 48377

United States

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan 48315

United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan 48322

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota 56601

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri 65613

United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri 63376

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri 63141

United States

Freeman Health System

Joplin, Missouri 64804

United States

Mercy Hospital Joplin

Joplin, Missouri 64804

United States

University of Kansas Cancer Center - North

Kansas City, Missouri 64154

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri 64116

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri 64506

United States

Mercy Hospital Springfield

Springfield, Missouri 65804

United States

CoxHealth South Hospital

Springfield, Missouri 65807

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Mercy Hospital South

St Louis, Missouri 63128

United States

Siteman Cancer Center-South County

St Louis, Missouri 63129

United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri 63136

United States

Mercy Hospital Saint Louis

St Louis, Missouri 63141

United States

Billings Clinic Cancer Center

Billings, Montana 59101

United States

Bozeman Deaconess Hospital

Bozeman, Montana 59715

United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana 59405

United States

Great Falls Clinic

Great Falls, Montana 59405

United States

Kalispell Regional Medical Center

Kalispell, Montana 59901

United States

Community Medical Hospital

Missoula, Montana 59804

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey 07645

United States

Northwell Health Imbert Cancer Center

Bay Shore, New York 11706

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York 11042

United States

Long Island Jewish Medical Center

New Hyde Park, New York 11040

United States

Lenox Hill Hospital

New York, New York 10021

United States

Mount Sinai Hospital

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of Rochester

Rochester, New York 14642

United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York 10461

United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York 10461

United States

Montefiore Medical Center - Moses Campus

The Bronx, New York 10467

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota 58501

United States

Sanford Broadway Medical Center

Fargo, North Dakota 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58122

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio 45219

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio 45069

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma 73120

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania 15009

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania 17109

United States

UPMC Jameson

New Castle, Pennsylvania 16105

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania 15213

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania 15232

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania 15237

United States

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania 15301

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota 57117-5134

United States

Parkland Memorial Hospital

Dallas, Texas 75235

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas 75390

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas 75080

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

Inova Fairfax Hospital

Falls Church, Virginia 22042

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin 54701

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin 54548

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin 54868

United States

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin 54482

United States

Marshfield Clinic-Wausau Center

Wausau, Wisconsin 54401

United States

Diagnostic and Treatment Center

Weston, Wisconsin 54476

United States

Marshfield Medical Center - Weston

Weston, Wisconsin 54476

United States

Welch Cancer Center

Sheridan, Wyoming 82801

United States