Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03493425

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

Led by ECOG-ACRIN Cancer Research Group ยท Updated on 2026-05-05

82

Participants Needed

140

Research Sites

524 weeks

Total Duration

On this page

Sponsors

E

ECOG-ACRIN Cancer Research Group

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • General physical condition suitable for chemotherapy and surgery
  • Histologically confirmed nasal and paranasal sinus squamous cell carcinoma (NPNSCC) at stage T3 or T4a requiring orbital or skull base resection
  • Surgical oncologist determination of the need for orbit or skull base removal before randomization
  • Surgically resectable tumor with a planned assessment of orbit and skull base preservation
  • No investigational agents received within 4 weeks before enrollment or during study
  • Ability to receive at least one of the proposed chemotherapy regimens
  • No evidence of distant metastases or leptomeningeal disease
  • No prior radiation to head and neck, skull base, or brain tumors
  • Adequate blood counts and kidney and liver function within 2 weeks prior to randomization
  • History of curatively treated squamous cell or basal skin carcinoma or in situ cervical cancer allowed
  • No peripheral neuropathy greater than grade 2 at randomization
  • No severe hypersensitivity to docetaxel or related drugs
  • Women must not be pregnant or breastfeeding and must have negative pregnancy test if of childbearing potential
  • Use of effective contraception or abstinence during study participation
  • Measurable disease confirmed by MRI and/or PET/CT within 2 weeks prior to registration
Not Eligible

You will not qualify if you...

  • Evidence of distant metastases or leptomeningeal disease
  • Prior radiation therapy to head and neck, skull base, or brain tumors
  • Uncontrolled inter-current illnesses that prevent chemotherapy or surgery
  • History of other malignancies unless disease-free for at least 2 years
  • Allergic reactions to docetaxel or platinum-based chemotherapy agents preventing use
  • Peripheral neuropathy greater than grade 2
  • Current pregnancy or breastfeeding
  • Severe hypersensitivity to drugs formulated with polysorbate 80
  • Inability to comply fully with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 140 locations

1

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States, 85704

Actively Recruiting

2

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

Actively Recruiting

3

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States, 85719

Actively Recruiting

4

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States, 72903

Actively Recruiting

5

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Withdrawn

6

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States, 94304

Actively Recruiting

7

VA Palo Alto Health Care System

Palo Alto, California, United States, 94304

Actively Recruiting

8

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

9

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

10

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States, 33146

Suspended

11

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Actively Recruiting

12

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

13

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States, 33324

Actively Recruiting

14

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States, 33607

Actively Recruiting

15

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States, 33612

Actively Recruiting

16

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

17

Emory Proton Therapy Center

Atlanta, Georgia, United States, 30308

Actively Recruiting

18

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

19

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

20

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States, 83706

Actively Recruiting

21

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States, 83605

Actively Recruiting

22

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States, 83814

Actively Recruiting

23

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States, 83642

Actively Recruiting

24

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States, 83686

Actively Recruiting

25

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States, 83854

Actively Recruiting

26

Rush - Copley Medical Center

Aurora, Illinois, United States, 60504

Actively Recruiting

27

Northwestern University

Chicago, Illinois, United States, 60611

Active, Not Recruiting

28

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

29

Carle on Vermilion

Danville, Illinois, United States, 61832

Actively Recruiting

30

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Actively Recruiting

31

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States, 60201

Actively Recruiting

32

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States, 60026

Actively Recruiting

33

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States, 60035

Actively Recruiting

34

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

Actively Recruiting

35

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States, 62864

Actively Recruiting

36

Carle Cancer Center

Urbana, Illinois, United States, 61801

Actively Recruiting

37

The Carle Foundation Hospital

Urbana, Illinois, United States, 61801

Actively Recruiting

38

Saint Anthony Regional Hospital

Carroll, Iowa, United States, 51401

Actively Recruiting

39

Iowa Methodist Medical Center

Des Moines, Iowa, United States, 50309

Actively Recruiting

40

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States, 50309

Actively Recruiting

41

Broadlawns Medical Center

Des Moines, Iowa, United States, 50314

Actively Recruiting

42

Iowa Lutheran Hospital

Des Moines, Iowa, United States, 50316

Actively Recruiting

43

Methodist West Hospital

West Des Moines, Iowa, United States, 50266-7700

Actively Recruiting

44

Central Care Cancer Center - Garden City

Garden City, Kansas, United States, 67846

Actively Recruiting

45

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States, 67530

Actively Recruiting

46

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66160

Active, Not Recruiting

47

Lawrence Memorial Hospital

Lawrence, Kansas, United States, 66044

Active, Not Recruiting

48

Olathe Health Cancer Center

Olathe, Kansas, United States, 66061

Active, Not Recruiting

49

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States, 66210

Active, Not Recruiting

50

Ascension Via Christi - Pittsburg

Pittsburg, Kansas, United States, 66762

Active, Not Recruiting

51

Salina Regional Health Center

Salina, Kansas, United States, 67401

Active, Not Recruiting

52

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States, 66606

Active, Not Recruiting

53

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States, 66205

Active, Not Recruiting

54

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

55

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Suspended

56

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

57

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States, 48183

Actively Recruiting

58

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States, 48038

Actively Recruiting

59

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States, 48126

Actively Recruiting

60

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

61

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

62

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

63

Allegiance Health

Jackson, Michigan, United States, 49201

Actively Recruiting

64

Henry Ford Medical Center-Columbus

Novi, Michigan, United States, 48377

Actively Recruiting

65

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, United States, 48315

Actively Recruiting

66

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States, 48322

Actively Recruiting

67

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States, 56601

Actively Recruiting

68

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States, 63011

Actively Recruiting

69

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States, 65613

Actively Recruiting

70

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States, 63376

Actively Recruiting

71

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States, 63141

Actively Recruiting

72

Freeman Health System

Joplin, Missouri, United States, 64804

Actively Recruiting

73

Mercy Hospital Joplin

Joplin, Missouri, United States, 64804

Actively Recruiting

74

University of Kansas Cancer Center - North

Kansas City, Missouri, United States, 64154

Active, Not Recruiting

75

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States, 64116

Active, Not Recruiting

76

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States, 65401

Actively Recruiting

77

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States, 65401

Actively Recruiting

78

Heartland Regional Medical Center

Saint Joseph, Missouri, United States, 64506

Actively Recruiting

79

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

Actively Recruiting

80

CoxHealth South Hospital

Springfield, Missouri, United States, 65807

Actively Recruiting

81

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

82

Mercy Hospital South

St Louis, Missouri, United States, 63128

Actively Recruiting

83

Siteman Cancer Center-South County

St Louis, Missouri, United States, 63129

Actively Recruiting

84

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States, 63136

Actively Recruiting

85

Mercy Hospital Saint Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

86

Billings Clinic Cancer Center

Billings, Montana, United States, 59101

Actively Recruiting

87

Bozeman Deaconess Hospital

Bozeman, Montana, United States, 59715

Actively Recruiting

88

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States, 59405

Actively Recruiting

89

Great Falls Clinic

Great Falls, Montana, United States, 59405

Actively Recruiting

90

Kalispell Regional Medical Center

Kalispell, Montana, United States, 59901

Actively Recruiting

91

Community Medical Hospital

Missoula, Montana, United States, 59804

Actively Recruiting

92

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

93

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

94

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

Actively Recruiting

95

Northwell Health Imbert Cancer Center

Bay Shore, New York, United States, 11706

Actively Recruiting

96

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

97

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States, 11042

Actively Recruiting

98

Long Island Jewish Medical Center

New Hyde Park, New York, United States, 11040

Actively Recruiting

99

Lenox Hill Hospital

New York, New York, United States, 10021

Actively Recruiting

100

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

101

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

102

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

103

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States, 10461

Actively Recruiting

104

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States, 10461

Actively Recruiting

105

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States, 10467

Actively Recruiting

106

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

107

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States, 58501

Actively Recruiting

108

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

109

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

110

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

111

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States, 45069

Actively Recruiting

112

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Active, Not Recruiting

113

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States, 73120

Actively Recruiting

114

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States, 15009

Actively Recruiting

115

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States, 15601

Actively Recruiting

116

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States, 17109

Actively Recruiting

117

UPMC Jameson

New Castle, Pennsylvania, United States, 16105

Suspended

118

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

119

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

120

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

121

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

122

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States, 15237

Actively Recruiting

123

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, United States, 15301

Actively Recruiting

124

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

125

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Actively Recruiting

126

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

Active, Not Recruiting

127

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Active, Not Recruiting

128

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States, 75080

Active, Not Recruiting

129

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

130

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

131

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States, 54701

Actively Recruiting

132

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States, 54449

Actively Recruiting

133

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Active, Not Recruiting

134

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States, 54548

Actively Recruiting

135

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States, 54868

Actively Recruiting

136

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, United States, 54482

Actively Recruiting

137

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States, 54401

Suspended

138

Diagnostic and Treatment Center

Weston, Wisconsin, United States, 54476

Actively Recruiting

139

Marshfield Medical Center - Weston

Weston, Wisconsin, United States, 54476

Actively Recruiting

140

Welch Cancer Center

Sheridan, Wyoming, United States, 82801

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz