RECRUITING

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

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Conditions

Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2019-03-12
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03493425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. * General physical condition compatible with the proposed chemotherapy and surgery
  3. * Stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection:
  4. * 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
  5. * 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
  6. * 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
  7. * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging
  8. * 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
  9. * 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
  10. * 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
  11. * Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded
  12. * Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
  13. * 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
  14. * Patients with a history of a different malignancy are excluded, unless the disease has not progressed for \>= 2 years
  15. * Absolute neutrophil count (ANC) \> 1500/mm\^3 =\< 2 weeks prior to randomization
  16. * Hemoglobin (Hgb) \> 8.0 g/dL =\< 2 weeks prior to randomization
  17. * Platelet count \> 100,000/mm\^3 =\< 2 weeks prior to randomization
  18. * 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
  19. * Total bilirubin within normal limits (must be obtained =\< 2 weeks prior to randomization)
  20. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the range allowing for eligibility, must be obtained \< 2 weeks prior to randomization
  21. * Alkaline phosphatase must be within the range allowing for eligibility, must be obtained \< 2 weeks prior to randomization
  22. * Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
  23. * No current peripheral neuropathy \> grade 2 at time of randomization
  24. * 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
  25. * Women must not be pregnant or breast-feeding
  26. * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  27. * 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)
  28. * 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
  29. * Patients must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to registration
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Nabil Saba
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
United States
VA Palo Alto Health Care System
Palo Alto, California, 94304
United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Yale University
New Haven, Connecticut, 06520
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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt Cancer Center
Tampa, Florida, 33612
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
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, 83686
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Rush - Copley Medical Center
Aurora, Illinois, 60504
United States
Northwestern University
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Carle on Vermilion
Danville, Illinois, 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
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
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
The Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
United States
Broadlawns Medical Center
Des Moines, Iowa, 50314
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700
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
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
United States
Olathe Health Cancer Center
Olathe, Kansas, 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
Ascension Via Christi - Pittsburg
Pittsburg, Kansas, 66762
United States
Salina Regional Health Center
Salina, Kansas, 67401
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
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
United States
Allegiance Health
Jackson, Michigan, 49201
United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, 48315
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Freeman Health System
Joplin, Missouri, 64804
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
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
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri, 63136
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901
United States
Community Medical Hospital
Missoula, Montana, 59804
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Lenox Hill Hospital
New York, New York, 10021
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
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 Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
United States
UPMC Jameson
New Castle, Pennsylvania, 16105
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
Parkland Memorial Hospital
Dallas, Texas, 75235
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482
United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States
Welch Cancer Center
Sheridan, Wyoming, 82801
United States

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

  • Nabil Saba, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-12
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2019-03-12
Study Completion Date2029-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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