Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
About this trial
This is an interventional treatment trial for Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- PHASE II INCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)
- Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx
- Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; Note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
- Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink)
Pathologic stage III or IV HNSCC, including no distant metastases, based upon the following minimum diagnostic workup:
- General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;
- Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation
- Pre-operative (op) Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave
- Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement
- Zubrod performance status of 0-1 within 14 days prior to registration
- Absolute granulocyte count (AGC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)
- Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)
- Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration
- Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
- Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential
- The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator's discretion
- Patients with feeding tubes are eligible for the study
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis
- PHASE III: Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx
- PHASE III: Patients with oropharyngeal cancer must have p16-negative based on central review prior to Step 2 registration; all patients with oropharyngeal primary must consent for mandatory tissue submission for central p16 confirmation
- PHASE III: Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration; note: patients may have biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but shortly recur or are determined to have persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
- PHASE III: Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor on ink or tumor in a final separately submitted margin)
PHASE III: Pathologic stage III or IV HNSCC (American Joint Committee on Cancer [AJCC] 7th edition), including no distant metastases, based upon the following minimum diagnostic workup:
- General history and physical examination by a radiation oncologist or medical oncologist within 84 days prior to registration;
- Examination by an ENT or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror or fiberoptic or direct procedure), if appropriate, is recommended but not required. Intra-operative examination is acceptable documentation.
- Pre-op Imaging of the head and neck: A neck CT (with contrast and of diagnostic quality) or PET/CT (with contrast and of diagnostic quality) and/or an MRI of the neck of diagnostic quality (T1 with gadolinium and T2) within 84 days prior to surgery; Note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in DICOM format via TRIAD. The report is to be uploaded into Rave.
- Chest CT scan (with or without contrast) or PET/CT that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; Note: If the PET/CT with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement
- PHASE III: Zubrod performance status of 0-1 within 14 days prior to registration
- PHASE III: Leukocytes >= 2,500 cells/mm^3 (obtained within 14 days prior to registration on study)
- PHASE III: Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)
- PHASE III: Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)
- PHASE III: Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable) (obtained within 14 days prior to registration on study)
- PHASE III: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x institutional ULN may be enrolled) (within 14 days prior to registration)
- PHASE III: AST or ALT =< 3 x institutional ULN (within 14 days prior to registration)
- PHASE III: Alkaline phosphatase =< 2.5 x institutional ULN (within 14 days prior to registration)
- PHASE III: Creatinine clearance (CrCl) >= 50 mL/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
- PHASE III: Patients with feeding tubes are eligible for the study
- PHASE III: Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential
- PHASE III: All patients must provide study specific informed consent prior to study entry
PHASE III: Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:
- A stable regimen of highly active anti-retroviral therapy (HAART);
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections;
- A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests
Exclusion Criteria:
- PHASE II EXCLUSION CRITERIA (COMPLETE AS OF 20-MAR-2020)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
- Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible
- Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration
- Transmural myocardial infarction within 6 months prior to registration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients.
- Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):
- Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
- Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)
- Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
- Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels
- Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Prior allergic reaction to cetuximab
- PHASE III: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) with the following exceptions: T1-2, N0, M0 resected differentiated thyroid carcinoma; Note that noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even if diagnosed and treated < 3 years ago
- PHASE III: Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible
- PHASE III: Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy (such as anti-EGF therapy), or immune therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, a prior anti-PD-1, anti-PD-L1, or anti-PD-L2 agent is not permitted
- PHASE III: Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
PHASE III: Severe, active co-morbidity, defined as follows:
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification; to be eligible for this trial, patients should be class 2B or better within 6 months prior to registration
- Transmural myocardial infarction within 6 months prior to registration;
- Severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in a prior radiation field (fibrosis) is permitted, provided that field does not overlap with the planned radiation field for the study cancer;
- Patients with active tuberculosis (TB) are excluded;
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease;
- Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface ant
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- The Kirklin Clinic at Acton Road
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- University of Arkansas for Medical Sciences
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Cameron ParkRecruiting
- Mercy San Juan Medical CenterRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Memorial Medical CenterRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Saint Helena Hospital
- UCSF Medical Center-Mount ZionRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Mills Health CenterRecruiting
- Sutter Cancer Centers Radiation Oncology Services-VacavilleRecruiting
- UCHealth University of Colorado Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Porter Adventist HospitalRecruiting
- Shaw Cancer CenterRecruiting
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Longmont United HospitalRecruiting
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- University of Connecticut
- Yale UniversityRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- George Washington University Medical CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- AdventHealth Orlando
- Orlando Health Cancer InstituteRecruiting
- Moffitt Cancer CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Augusta University Medical CenterRecruiting
- Memorial Health University Medical CenterRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Queen's Medical Center
- The Cancer Center of Hawaii-Liliha
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Northwestern University
- John H Stroger Jr Hospital of Cook CountyRecruiting
- Rush University Medical CenterRecruiting
- University of Illinois
- Decatur Memorial HospitalRecruiting
- Crossroads Cancer CenterRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Advocate Christ Medical Center
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- OSF Saint Francis Medical CenterRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Ascension Saint Vincent Anderson
- Elkhart General Hospital
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Goshen Center for Cancer Care
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Methodist Hospital
- IU Health Central Indiana Cancer Centers-East
- Michiana Hematology Oncology PC-Mishawaka
- Memorial Hospital of South Bend
- McFarland Clinic - Ames
- Iowa Methodist Medical Center
- University of Kansas Cancer CenterRecruiting
- Olathe Health Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- Salina Regional Health CenterRecruiting
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- Tulane University Health Sciences Center
- Ochsner Medical Center Jefferson
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Greater Baltimore Medical CenterRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Central Maryland Radiation Oncology in Howard CountyRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Holy Cross Hospital
- Boston Medical Center
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer Center
- Saint Joseph Mercy BrightonRecruiting
- University of Michigan - Brighton Center for Specialty Care
- Henry Ford Cancer Institute-DownriverRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford HospitalRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- West Michigan Cancer CenterRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's HospitalRecruiting
- William Beaumont Hospital - Troy
- Henry Ford West Bloomfield HospitalRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- University of Mississippi Medical Center
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Siteman Cancer Center at West County HospitalRecruiting
- North Kansas City Hospital
- The University of Kansas Cancer Center-South
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- CHI Health Good SamaritanRecruiting
- Nebraska Methodist Hospital
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Virtua Memorial
- Sparta Cancer Treatment Center
- Virtua Voorhees
- University of New Mexico Cancer CenterRecruiting
- New Mexico Oncology Hematology ConsultantsRecruiting
- South Shore University Hospital
- New York-Presbyterian/Brooklyn Methodist Hospital
- Roswell Park Cancer InstituteRecruiting
- Sands Cancer CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Arnot Ogden Medical Center/Falck Cancer CenterRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced Medicine
- NYU Winthrop HospitalRecruiting
- Mount Sinai Union SquareRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer CenterRecruiting
- Wilmot Cancer Institute Radiation Oncology at Greece
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Memorial Sloan Kettering Sleepy Hollow
- State University of New York Upstate Medical UniversityRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Atrium Health Stanly/LCI-AlbemarleRecruiting
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- East Carolina University
- Vidant Oncology-KinstonRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Wake Forest University Health Sciences
- Sanford Bismarck Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- Summa Health System - Barberton Campus
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Geauga HospitalRecruiting
- Adena Regional Medical CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mercy Cancer Center-Elyria
- Cleveland Clinic Cancer Center Independence
- OhioHealth Mansfield HospitalRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical Center
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- University of Cincinnati Cancer Center-West Chester
- UHHS-Westlake Medical CenterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Carlisle Regional Cancer CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- IRMC Cancer CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- UPMC Cancer Center at UPMC McKeesportRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- UPMC Cancer Center-Natrona Heights
- UPMC Jameson
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Temple University HospitalRecruiting
- Allegheny General HospitalRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- Reading Hospital
- Wexford Health and Wellness PavilionRecruiting
- AnMed Health Cancer Center
- Saint Joseph's/Candler - Bluffton Campus
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Spartanburg Medical CenterRecruiting
- Rapid City Regional Hospital
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt University/Ingram Cancer Center
- MD Anderson in The WoodlandsRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- University of Texas Medical Branch
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- UTMB Cancer Center at Victory Lakes
- Covenant Medical Center-Lakeside
- MD Anderson in Sugar LandRecruiting
- Intermountain Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of UtahRecruiting
- Inova Fairfax Hospital
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Sentara Norfolk General Hospital
- Virginia Commonwealth University/Massey Cancer Center
- Sentara Virginia Beach General Hospital
- Saint Francis Hospital
- Tri-Cities Cancer Center
- PeaceHealth Saint John Medical CenterRecruiting
- Skagit Regional Health Cancer Care CenterRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- Spokane Valley Cancer Center-Mayfair
- Spokane Valley Cancer Center-Mission
- Wenatchee Valley Hospital and ClinicsRecruiting
- West Virginia University HealthcareRecruiting
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer CenterRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Mayo Clinic Health System-Franciscan Healthcare
- University of Wisconsin Carbone Cancer CenterRecruiting
- Bay Area Medical Center
- Marshfield Medical Center
- Froedtert Menomonee Falls HospitalRecruiting
- Medical College of WisconsinRecruiting
- Marshfield Clinic-Minocqua Center
- Drexel Town Square Health CenterRecruiting
- Ascension Saint Michael's Hospital
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Cross Cancer Institute
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Chinese University of Hong Kong-Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm 1 (IMRT, cisplatin)
Arm 2 (IMRT, docetaxel)
Arm 3 (IMRT, docetaxel, cetuximab)
Arm 4 (IMRT, cisplatin, atezolizumab)
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.
Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)
Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.