Chemo before surgery may save eye and skull in sinus cancer patients

NCT ID NCT03493425

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This study tests whether giving chemotherapy before surgery and radiation can help preserve the eye and skull base in people with advanced nasal and sinus cancer. About 82 participants will either get chemo first or go straight to surgery and radiation. The goal is to see if the chemo shrinks the tumor enough to avoid removing the eye or skull base.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: chemotherapy (docetaxel, cisplatin, carboplatin)
What this could lead to: If it works, this approach could help more people with advanced sinus cancer keep their eye and skull base structures while still treating the cancer effectively.
What could go wrong: This is a phase 2 trial with only 82 participants, so results are preliminary. Chemotherapy can cause side effects like infection, fatigue, and organ damage, and it may not improve outcomes over standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must be \>= 18 years of age * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients must have a general physical condition compatible with the proposed chemotherapy and surgery * Patients must have stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some patients with T4b disease deemed resectable by the treating surgeon can be included provided they fulfill all other eligibility criteria without involvement of the cavernous sinus * Patients with T4b who have the following characteristics leading to a T4b definition but who in the opinion of the treating surgeon can have resectable disease can be included provided they fulfill all other eligibility criteria and provided they have one of the following presentations: 1. Invasion of orbital apex without involvement of the cavernous sinus 2. Dura invasion depending on extent of involvement and if total resection is deemed feasible. 3. Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible. 4. Nasopharynx invasion if very limited 5. Clivus invasion if very limited. (Surgeons are encouraged to consult with the protocol surgical chair for these particular cases). Stages T3 and T4a and selected T4b disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection. The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neoadjuvant chemotherapy for patients on Arm B using the score sheet provided at the end of the protocol. * Resection of skull base will be deemed necessary according to skull base bone erosion by computed tomography (CT) or marrow involvement by magnetic resonance imaging (MRI) is noted; for any disease abutting the skull base * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging * Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization * Patients 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

nasal cavity and paranasal sinus squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III nasal cavity and paranasal sinus squamous cell carcinoma ajcc V6 and V7 Stage III sinonasal squamous cell carcinoma ajcc V6 and V7 Stage IVA nasal cavity and paranasal sinus squamous cell carcinoma ajcc V7 Stage IVA sinonasal squamous cell carcinoma ajcc V7

Contacts and locations

Locations

Allegiance Health

Jackson, Michigan, 49201, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Broadlawns Medical Center

Des Moines, Iowa, 50314, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015, United States
Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, 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
Community Medical Center

Missoula, Montana, 59804, United States
CoxHealth South Hospital

Springfield, Missouri, 65807, United States
Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, 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
Freeman Health System

Joplin, Missouri, 64804, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States
Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, 48315, United States
Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States
Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642, United States
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States
Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States
Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Lenox Hill Hospital

New York, New York, 10075, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States
Manhattan Eye Ear and Throat Hospital

New York, New York, 10065, United States
Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States
Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States
Mercy Hospital Joplin

Joplin, Missouri, 64804, United States
Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States
Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital South

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, 63011, United States
Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States
Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, 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
Mount Sinai Chelsea

New York, New York, 10011, United States
Mount Sinai Hospital

New York, New York, 10029, United States
Mount Sinai Union Square

New York, New York, 10003, 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
Northwell Health Imbert Cancer Center

Bay Shore, New York, 11706, United States
Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States
Northwestern University

Chicago, Illinois, 60611, United States
Parkland Memorial Hospital

Dallas, Texas, 75235, United States
Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States
Rush-Copley Medical Center

Aurora, Illinois, 60504, United States
SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States
Saint Anthony Regional Hospital

Carroll, Iowa, 51401, United States
Saint Mary's Hospital

Centralia, Illinois, 62801, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, 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
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
The Carle Foundation Hospital

Urbana, Illinois, 61801, United States
The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States
The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, 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
UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121, United States
UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States
UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, 15108, United States
UPMC Jameson

New Castle, Pennsylvania, 16105, United States
UPMC Memorial

York, Pennsylvania, 17408, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States
UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, 15301, United States
UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009, United States
UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States
UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States
UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States
UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, 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 Illinois

Chicago, Illinois, 60612, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, 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
University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, 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
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States
Welch Cancer Center

Sheridan, Wyoming, 82801, United States
Yale University

New Haven, Connecticut, 06520, United States

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