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

Last updated: December 19, 2024
Sponsor: ECOG-ACRIN Cancer Research Group
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Treatment

Laboratory Biomarker Analysis

Intensity-Modulated Radiation Therapy

Therapeutic Conventional Surgery

Clinical Study ID

NCT03493425
EA3163
EA3163
U10CA180820
NCI-2017-01364
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 82
Treatment Group(s): 8
Primary Treatment: Laboratory Biomarker Analysis
Phase: 2
Study Start date:
March 12, 2019
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Banner University Medical Center - Tucson

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas 72903
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • VA Palo Alto Health Care System

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida 33146
    United States

    Suspended

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida 33442
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Emory Proton Therapy Center

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho 83605
    United States

    Active - Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho 83814
    United States

    Active - Recruiting

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho 83686
    United States

    Active - Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho 83854
    United States

    Active - Recruiting

  • Rush - Copley Medical Center

    Aurora, Illinois 60504
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Carle on Vermilion

    Danville, Illinois 61832
    United States

    Active - Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois 62401
    United States

    Active - Recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois 60035
    United States

    Active - Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois 61938
    United States

    Active - Recruiting

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois 62864
    United States

    Active - Recruiting

  • Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Active - Recruiting

  • The Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Active - Recruiting

  • Saint Anthony Regional Hospital

    Carroll, Iowa 51401
    United States

    Active - Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa 50316
    United States

    Active - Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Methodist West Hospital

    West Des Moines, Iowa 50266-7700
    United States

    Active - Recruiting

  • Central Care Cancer Center - Garden City

    Garden City, Kansas 67846
    United States

    Active - Recruiting

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas 67530
    United States

    Active - Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Lawrence Memorial Hospital

    Lawrence, Kansas 66044
    United States

    Site Not Available

  • Olathe Health Cancer Center

    Olathe, Kansas 66061
    United States

    Site Not Available

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Ascension Via Christi - Pittsburg

    Pittsburg, Kansas 66762
    United States

    Site Not Available

  • Salina Regional Health Center

    Salina, Kansas 67401
    United States

    Site Not Available

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas 66606
    United States

    Site Not Available

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Suspended

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan 48183
    United States

    Active - Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan 48038
    United States

    Active - Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan 48126
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Allegiance Health

    Jackson, Michigan 49201
    United States

    Active - Recruiting

  • Henry Ford Medical Center-Columbus

    Novi, Michigan 48377
    United States

    Active - Recruiting

  • Henry Ford Macomb Health Center - Shelby Township

    Shelby, Michigan 48315
    United States

    Active - Recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan 48322
    United States

    Active - Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota 56601
    United States

    Active - Recruiting

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri 63011
    United States

    Active - Recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri 65613
    United States

    Active - Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri 63141
    United States

    Active - Recruiting

  • Freeman Health System

    Joplin, Missouri 64804
    United States

    Active - Recruiting

  • Mercy Hospital Joplin

    Joplin, Missouri 64804
    United States

    Active - Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri 65401
    United States

    Active - Recruiting

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri 65401
    United States

    Active - Recruiting

  • Heartland Regional Medical Center

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Mercy Hospital South

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • Siteman Cancer Center at Christian Hospital

    Saint Louis, Missouri 63136
    United States

    Active - Recruiting

  • Siteman Cancer Center-South County

    Saint Louis, Missouri 63129
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    Saint Peters, Missouri 63376
    United States

    Active - Recruiting

  • CoxHealth South Hospital

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri 65804
    United States

    Active - Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana 59101
    United States

    Active - Recruiting

  • Bozeman Deaconess Hospital

    Bozeman, Montana 59715
    United States

    Active - Recruiting

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana 59405
    United States

    Active - Recruiting

  • Great Falls Clinic

    Great Falls, Montana 59405
    United States

    Active - Recruiting

  • Kalispell Regional Medical Center

    Kalispell, Montana 59901
    United States

    Active - Recruiting

  • Community Medical Hospital

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Campus

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Montefiore Medical Center-Einstein Campus

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore Medical Center-Weiler Hospital

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    New York, New York 10021
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota 58501
    United States

    Active - Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota 58122
    United States

    Active - Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota 58122
    United States

    Active - Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio 45069
    United States

    Active - Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania 15009
    United States

    Active - Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania 15601
    United States

    Active - Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania 17109
    United States

    Active - Recruiting

  • UPMC Jameson

    New Castle, Pennsylvania 16105
    United States

    Suspended

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania 15237
    United States

    Active - Recruiting

  • UPMC-Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania 15301
    United States

    Active - Recruiting

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota 57117-5134
    United States

    Active - Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas 75235
    United States

    Site Not Available

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas 75080
    United States

    Site Not Available

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin 54701
    United States

    Active - Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin 54548
    United States

    Active - Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin 54868
    United States

    Active - Recruiting

  • Marshfield Clinic Stevens Point Center

    Stevens Point, Wisconsin 54482
    United States

    Active - Recruiting

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin 54401
    United States

    Suspended

  • Diagnostic and Treatment Center

    Weston, Wisconsin 54476
    United States

    Active - Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin 54476
    United States

    Active - Recruiting

  • Welch Cancer Center

    Sheridan, Wyoming 82801
    United States

    Active - Recruiting

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