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RECRUITING

NCT03493425

PHASE2

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

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-03-12

Completion Date

2029-03-31

Last Updated

2026-03-23

Healthy Volunteers

Conditions

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

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Docetaxel

Given IV

RADIATION

Image Guided Radiation Therapy

Undergo image guided IMRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo image guided IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

Undergo standard of care surgery

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

Locations (140)

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Carle on Vermilion

Danville, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Olathe Health Cancer Center

Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Ascension Via Christi - Pittsburg

Pittsburg, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Washington University School of Medicine