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

NCT ID: NCT01810913

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-22

Study Completion Date

2027-01-01

Brief Summary

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This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

Detailed Description

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PRIMARY OBJECTIVES:

I. To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. (Phase II) (COMPLETE AS OF 20-MAR-2020) II. To determine if the combination of docetaxel-cetuximab and intensity-modulated radiation therapy (IMRT) is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). (Phase III) III. To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC. (Phase III)

SECONDARY OBJECTIVES:

I. To compare disease-free survival (DFS) between each experimental arm and the control arm. (Phase III) II. To determine whether each experimental arm improves local-regional disease control and the rate of distant metastasis. (Phase III) III. To compare acute toxicity profiles between each experimental arm and the control arm. (Phase III) IV. To compare late toxicity profiles at 1, 3, and 5 years after treatment. (Phase III) V. To assess long term DFS and OS between each experimental arm and the control arm. (Phase III) VI. To compare symptom burden, as measured by the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) (primary patient reported outcome \[PRO\]), and quality of life, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) (secondary PRO), between each experimental arm and the control arm. (Phase III)

EXPLORATORY OBJECTIVE:

I. To collect blood and tissue specimens for future translational research. (Phase III)

OUTLINE: Patients are randomized to 1 of 3 arms - Phase II (Arms 1, 2 or 3) and for Phase III (Arms 1, 3 or 4).

ARM 1: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks and receive concurrent cisplatin intravenously (IV) over 1-2 hours once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. (CLOSED AS OF 20-MAR-2020)

ARM 3: 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 concurrently receive docetaxel once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM 4: 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.

All patients undergo collection of blood samples during screening and throughout the study and may undergo computed tomography (CT) scans and/or magnetic resonance imaging (MRI) and biopsy as clinically indicated on study.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

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Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7 Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (IMRT, cisplatin)

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 in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cisplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm 2 (IMRT, docetaxel)

Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Docetaxel

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm 3 (IMRT, docetaxel, cetuximab)

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 in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cetuximab

Intervention Type BIOLOGICAL

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Docetaxel

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Survey Administration

Intervention Type OTHER

Ancillary studies

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. 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 collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Given IV

Biopsy Procedure

Intervention Type PROCEDURE

Undergo biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cisplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Atezolizumab

Given IV

Intervention Type DRUG

Biopsy Procedure

Undergo biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Cetuximab

Given IV

Intervention Type BIOLOGICAL

Cisplatin

Given IV

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Docetaxel

Given IV

Intervention Type DRUG

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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MPDL 3280A MPDL 328OA MPDL-3280A MPDL3280A MPDL328OA RG 7446 RG-7446 RG7446 RO 5541267 RO-5541267 RO5541267 Tecentriq Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection C 225 C-225 C225 Cetuximab Biosimilar CDP-1 Cetuximab Biosimilar CMAB009 Cetuximab Biosimilar KL 140 Chimeric Anti-EGFR Monoclonal Antibody Chimeric MoAb C225 Chimeric Monoclonal Antibody C225 Erbitux IMC-C225 Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Docecad RP 56976 RP-56976 RP56976 Taxotere Taxotere Injection Concentrate IMRT Intensity modulated radiation therapy (procedure) Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI

Eligibility Criteria

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Inclusion Criteria

* 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
* Age \>= 18
* 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: Age \>= 18
* 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

* 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 antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible.
* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
* History of allogeneic bone marrow transplantation or solid organ transplantation.
* A diagnosis of immunodeficiency:

* Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note: 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.
* Is receiving treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration.

* Note: Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
* Note: The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
* History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

* Patients with a history of autoimmune hypothyroidism who are asymptomatic and/or are on a stable dose of thyroid replacement hormone are eligible.
* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
* Rash must cover less than 10% of body surface area (BSA)
* Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
* No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
* PHASE III: Grade 3-4 electrolyte abnormalities (CTCAE, v. 4) within 14 days prior to registration:

* 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.
* PHASE III: Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for up to 5 months from last study treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding and unwilling to discontinue are also excluded
* PHASE III: History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* PHASE III: Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other non-oncologic reasons (e.g., osteoporosis) is allowed
* PHASE III: Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) for non-oncologic reasons who cannot discontinue it before registration
* PHASE III: Patients with known distant metastatic disease are excluded
* PHASE III: Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* PHASE III: Major surgical procedure within 28 days prior to registration or anticipation of need for a major surgical procedure during the course of the study
* PHASE III: Administration of a live, attenuated vaccine within 4 weeks prior to registration or anticipation that such a live, attenuated vaccine will be required during the study and for patients receiving atezolizumab, up to 5 months after the last dose of atezolizumab.

* Influenza vaccination should be given during influenza season only (approximately October to
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NRG Oncology

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul M Harari

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status ACTIVE_NOT_RECRUITING

The Kirklin Clinic at Acton Road

Birmingham, Alabama, United States

Site Status SUSPENDED

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status RECRUITING

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status RECRUITING

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status RECRUITING

UC San Diego Health System - Encinitas

Encinitas, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Memorial Medical Center

Modesto, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status ACTIVE_NOT_RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status SUSPENDED

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Site Status SUSPENDED

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status SUSPENDED

Mills Health Center

San Mateo, California, United States

Site Status RECRUITING

Saint Helena Hospital

St. Helena, California, United States

Site Status ACTIVE_NOT_RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status RECRUITING

AdventHealth Porter

Denver, Colorado, United States

Site Status RECRUITING

Shaw Cancer Center

Edwards, Colorado, United States

Site Status RECRUITING

Banner North Colorado Medical Center

Greeley, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Longmont United Hospital

Longmont, Colorado, United States

Site Status RECRUITING

Banner McKee Medical Center

Loveland, Colorado, United States

Site Status SUSPENDED

AdventHealth Parker

Parker, Colorado, United States

Site Status RECRUITING

University of Connecticut

Farmington, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status SUSPENDED

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status SUSPENDED

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

AdventHealth Orlando

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Augusta University Medical Center

Augusta, Georgia, United States

Site Status RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status RECRUITING

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status SUSPENDED

Northwestern University

Chicago, Illinois, United States

Site Status SUSPENDED

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Site Status RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Ascension Saint Vincent Anderson

Anderson, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Radiation Oncology Associates PC

Fort Wayne, Indiana, United States

Site Status SUSPENDED

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status SUSPENDED

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status SUSPENDED

IU Health Central Indiana Cancer Centers-East

Indianapolis, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status ACTIVE_NOT_RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status RECRUITING

Salina Regional Health Center

Salina, Kansas, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status ACTIVE_NOT_RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Touro Infirmary

New Orleans, Louisiana, United States

Site Status RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status ACTIVE_NOT_RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Site Status RECRUITING

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

Site Status RECRUITING

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Site Status RECRUITING

Holy Cross Hospital

Silver Spring, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Site Status RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Allegiance Health

Jackson, Michigan, United States

Site Status RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Site Status RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status SUSPENDED

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status SUSPENDED

The University of Kansas Cancer Center-South

Kansas City, Missouri, United States

Site Status SUSPENDED

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status RECRUITING

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status RECRUITING

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, United States

Site Status RECRUITING

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status RECRUITING

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

Virtua Memorial

Mount Holly, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status RECRUITING

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status RECRUITING

Sparta Cancer Treatment Center

Sparta, New Jersey, United States

Site Status SUSPENDED

Community Medical Center

Toms River, New Jersey, United States

Site Status RECRUITING

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status RECRUITING

South Shore University Hospital

Bay Shore, New York, United States

Site Status ACTIVE_NOT_RECRUITING

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status SUSPENDED

NYU Langone Hospital - Brooklyn

Brooklyn, New York, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Sands Cancer Center

Canandaigua, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, United States

Site Status SUSPENDED

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status ACTIVE_NOT_RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status RECRUITING

Mount Sinai Union Square

New York, New York, United States

Site Status RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute Radiation Oncology at Greece

Rochester, New York, United States

Site Status RECRUITING

Highland Hospital

Rochester, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Sleepy Hollow

Sleepy Hollow, New York, United States

Site Status ACTIVE_NOT_RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status RECRUITING

Atrium Health Stanly/LCI-Albemarle

Albemarle, North Carolina, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

ECU Health Oncology Kinston

Kinston, North Carolina, United States

Site Status RECRUITING

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

Site Status RECRUITING

Summa Health System - Barberton Campus

Barberton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status RECRUITING

Geauga Hospital

Chardon, Ohio, United States

Site Status RECRUITING

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status SUSPENDED

Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status SUSPENDED

Cleveland Clinic Cancer Center Independence

Independence, Ohio, United States

Site Status SUSPENDED

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status SUSPENDED

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Summa Health Medina Medical Center

Medina, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

Site Status RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status RECRUITING

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status RECRUITING

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

Site Status RECRUITING

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status SUSPENDED

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, United States

Site Status RECRUITING

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status RECRUITING

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Site Status RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

IRMC Cancer Center

Indiana, Pennsylvania, United States

Site Status RECRUITING

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center-Natrona Heights

Natrona Heights, Pennsylvania, United States

Site Status SUSPENDED

UPMC Jameson

New Castle, Pennsylvania, United States

Site Status SUSPENDED

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC Jefferson Regional Radiation Oncology

Pittsburgh, Pennsylvania, United States

Site Status SUSPENDED

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status RECRUITING

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, United States

Site Status RECRUITING

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital

West Reading, Pennsylvania, United States

Site Status SUSPENDED

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, United States

Site Status RECRUITING

AnMed Health Cancer Center

Anderson, South Carolina, United States

Site Status SUSPENDED

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status SUSPENDED

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status RECRUITING

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status RECRUITING

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

MD Anderson West Houston

Houston, Texas, United States

Site Status RECRUITING

MD Anderson League City

League City, Texas, United States

Site Status RECRUITING

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Covenant Medical Center-Lakeside

Lubbock, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Site Status RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status ACTIVE_NOT_RECRUITING

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status ACTIVE_NOT_RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Saint George Regional Medical Center

St. George, Utah, United States

Site Status ACTIVE_NOT_RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Francis Hospital

Federal Way, Washington, United States

Site Status SUSPENDED

Tri-Cities Cancer Center

Kennewick, Washington, United States

Site Status SUSPENDED

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status RECRUITING

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington, United States

Site Status RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status RECRUITING

Spokane Valley Cancer Center-Mayfair

Spokane, Washington, United States

Site Status SUSPENDED

Spokane Valley Cancer Center-Mission

Spokane, Washington, United States

Site Status SUSPENDED

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Site Status RECRUITING

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status RECRUITING

Camden Clark Medical Center

Parkersburg, West Virginia, United States

Site Status RECRUITING

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, United States

Site Status RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status WITHDRAWN

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Marshfield Medical Center

Marshfield, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status SUSPENDED

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status SUSPENDED

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status SUSPENDED

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status SUSPENDED

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status SUSPENDED

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status SUSPENDED

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status ACTIVE_NOT_RECRUITING

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China United States Canada Hong Kong

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2013-00500

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG-1216

Identifier Type: OTHER

Identifier Source: secondary_id

RTOG-1216

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA021661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2013-00500

Identifier Type: -

Identifier Source: org_study_id

NCT04411121

Identifier Type: -

Identifier Source: nct_alias