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Brief 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
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)
Study ID: NCT03493425
Brief 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.
Detailed Description: PRIMARY OBJECTIVES: I. 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: I. 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 fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation. V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. TERTIARY OBJECTIVES: I. 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 courses 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 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
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Northwell Health Imbert Cancer Center, Bay Shore, New York, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Lenox Hill Hospital, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg, Pennsylvania, United States
UPMC Jameson, New Castle, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC-Presbyterian Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology, Washington, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Nabil Saba
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR