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Spots Global Cancer Trial Database for 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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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Nabil Saba

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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