AzTrials
AzTrials

Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7Phase 2NCT03493425

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

A Phase 2 study testing Carboplatin, Cisplatin and Docetaxel in people with Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7, run by ECOG-ACRIN Cancer Research Group at 154 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Cisplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
154 sitesUnited States
Study dates
12 Mar 2019to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
  • 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 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

Who cannot join

  • 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 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
  • 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

Trial locations and contacts

154 sites in 1 country.

154 sites in 1 country

United States154 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Allegiance Health

    Jackson, Michigan, 49201

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

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

    Miami, Florida, 33136

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • UPMC Jameson

    New Castle, Pennsylvania, 16105

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Mount Sinai Union Square

    New York, New York, 10003

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Mount Sinai Hospital

    New York, New York, 10029

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762

  • UPMC-Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • University of Rochester

    Rochester, New York, 14642

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Dartmouth Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Henry Ford Macomb Health Center - Shelby Township

    Shelby, Michigan, 48315

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • UPMC Memorial

    York, Pennsylvania, 17408

Other trials in United States

About this study

Official title: Phase II Randomized Trial of Neoadjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a (and Selected T4b) Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival.

EXPLORATORY TOBACCO USE OBJECTIVES:

  1. 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.

Being tested
Carboplatin, Cisplatin, Docetaxel, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy

    Undergo image guided IMRT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo image guided IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo standard of care surgery

Study groups in NCT03493425
Study groupRoleWhat they receive
Arm A (surgery, IMRT, cisplatin, carboplatin)Active comparatorPatients 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.
Receives: Drug: Carboplatin; Drug: Cisplatin; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Therapeutic Conventional Surgery
Arm B (docetaxel, cisplatin, carboplatin, surgery, IMRT)ExperimentalPatients 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 or carboplatin IV weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Structure preservation rate defined as both skull base and orbit being preserved

    Fisher's exact test will be used to compare the structure preservation rate between the two arms. The comparison between the two arms for structure preservation will be conducted separately (each at one-sided 0.05 significance level).

    Measured: Up to 5 years

  2. Overall survival (OS)

    Log rank test will be used to compare OS between the two arms. The comparison between the two arms for OS will be conducted separately (each at one-sided 0.05 significance level).

    Measured: From date of randomization, censoring follow-up at last date of contact, assessed for up to 5 years

Secondary outcomes (2)

  1. Change in accuracy of magnetic resonance imaging (MRI) and fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT) to predict orbital and skull base preservation

    Receiver operating characteristic (ROC) analysis will be used to assess the ability of using imaging to predict structure preservation. The optimal cut-off points on the ROC curves will be determined by using the Youden's index, which will be used to create the two groups of the baseline/post-chemotherapy MRI markers. Cross-validation will be used to reduce overfitting in the discovery of the optimal cut-off points. After the dichotomization, the structure preservation rate will be computed in each group. The comparison will be done by using Fisher's Exact test. Will repeat the similar analyses using FDG PET/CT and the imaging biomarkers will include standardized uptake value (maximum standardized uptake value and peak standardized uptake value), metabolic tumor volume, total lesion glycolysis, and tumor metabolic heterogeneity derived from PET/CT.

    Measured: Baseline and post-chemotherapy

  2. OS by imaging biomarkers

    The imaging biomarkers from MRI will include apparent diffusion coefficient from diffusion weighted MRI and tumor volume and margins from gadolinium enhanced T1 images and from PET/CT include focal FDG uptake (greater than liver FDG uptake) involving orbit and skull base, maximum standard uptake value, peak standard uptake value, metabolic tumor volume and total lesion glycolysis. The 2-year OS curve rate will be computed in each group.

    Measured: From date of randomization, censoring follow-up at last date of contact, assessed at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start12 Mar 2019
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493425
Sponsor's protocol ID
EA3163
Other IDs
NCI-2017-01364, EA3163, EA3163, U10CA180820
Status last verified
Sep 2026
First submitted
26 Jan 2018
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35080076

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cisplatin and Docetaxel in people with Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7 and Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7, run by ECOG-ACRIN Cancer Research Group at 154 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Structure preservation rate defined as both skull base and orbit being preserved (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03493425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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