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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT01810913
Collaborator
NRG Oncology (Other)
613
286
4
165.5
2.1
0

Study Details

Study Description

Brief Summary

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

PRIMARY OBJECTIVES:
  1. 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
    1. 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:
  1. 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:
  1. 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.

ARM 2: Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. (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.

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.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
613 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II/III Trial of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
Actual Study Start Date :
Mar 18, 2013
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Cisplatin
Given IV
Other Names:
  • 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
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Experimental: Arm 2 (IMRT, docetaxel)

    Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. (CLOSED AS OF 20-MAR-2020)

    Drug: Docetaxel
    Given IV
    Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Experimental: 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.

    Biological: Cetuximab
    Given IV
    Other Names:
  • 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
  • Drug: Docetaxel
    Given IV
    Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Experimental: 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.

    Drug: Atezolizumab
    Given IV
    Other Names:
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL3280A
  • MPDL328OA
  • RG7446
  • RO5541267
  • Tecentriq
  • Drug: Cisplatin
    Given IV
    Other Names:
  • 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
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival (DFS) (Phase II) [From date of randomization until date of local-regional recurrence, distant metastasis or death due to any cause, assessed up to 7 years]

      Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test.

    2. Overall survival (OS) (Phase III) [From date of randomization to death due to any cause, assessed up to 7 years]

      Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a one-sided log rank test. Multivariate analysis will be performed using the Cox proportional hazards model.

    Secondary Outcome Measures

    1. Local-regional failure (LRF) [From date of randomization until date of local-regional recurrence, assessed up to 7 years]

      The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.

    2. Distant metastasis (DM) [From date of randomization to date of distant metastasis, assessed up to 7 years]

      The cumulative incidence method will be used to estimate rates, and the failure rates for the experimental arms will be compared against the control using a failure-specific log rank test.

    3. Toxicity [From start of treatment to death or last follow-up]

      Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. Rates of grade 3+ adverse events overall will be compared between arms by Chi-square test, or Fisher's exact test.

    4. Patient-reported outcome, symptom burden [Time from randomization to a first recovery within at least one MID unit of total symptom severity compared to the baseline (reference) score]

      Time to recovery of baseline total symptom severity from the MD Anderson Symptom Inventory - Head and Neck (MDASI-HN). The cumulative incidence method will be used to estimate the event rates, and the event rates between arms will be compared using a cause-specific log rank test. The Fine-Gray subdistribution hazards model may be applied to further explore outcomes by treatment arm and other covariates.

    5. Quality of life [Baseline and 1 year post radiation therapy (RT)]

      Quality of life change from baseline at 1-year post RT, as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Trial Outcome Index (TOI). FACT TOI is a validated efficient summary index of physical/functional outcomes, and disease site-specific items, which is highly reliable and sensitive to change in performance status rating. A constrained longitudinal data analysis model will be fitted with all the time points (discrete), the treatment factor and its interaction. The secondary non-inferiority patient-reported outcome (PRO) hypothesis will be tested using a confidence interval approach.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 The Kirklin Clinic at Acton Road Birmingham Alabama United States 35243
    3 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    4 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    5 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    6 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
    7 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    8 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
    9 Mercy San Juan Medical Center Carmichael California United States 95608
    10 UC San Diego Moores Cancer Center La Jolla California United States 92093
    11 Cedars Sinai Medical Center Los Angeles California United States 90048
    12 Memorial Medical Center Modesto California United States 95355
    13 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    14 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    15 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    16 Sutter Medical Center Sacramento Sacramento California United States 95816
    17 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    18 Saint Helena Hospital Saint Helena California United States 94574
    19 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    20 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    21 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
    22 University of Colorado Hospital Aurora Colorado United States 80045
    23 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    24 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    25 Porter Adventist Hospital Denver Colorado United States 80210
    26 Shaw Cancer Center Edwards Colorado United States 81632
    27 North Colorado Medical Center Greeley Colorado United States 80631
    28 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    29 Longmont United Hospital Longmont Colorado United States 80501
    30 McKee Medical Center Loveland Colorado United States 80539
    31 Parker Adventist Hospital Parker Colorado United States 80138
    32 University of Connecticut Farmington Connecticut United States 06030
    33 Yale University New Haven Connecticut United States 06520
    34 Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut United States 06385
    35 Helen F Graham Cancer Center Newark Delaware United States 19713
    36 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    37 George Washington University Medical Center Washington District of Columbia United States 20037
    38 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    39 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    40 AdventHealth Orlando Orlando Florida United States 32803
    41 Orlando Health Cancer Institute Orlando Florida United States 32806
    42 Moffitt Cancer Center Tampa Florida United States 33612
    43 Emory University Hospital Midtown Atlanta Georgia United States 30308
    44 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    45 Augusta University Medical Center Augusta Georgia United States 30912
    46 Memorial Health University Medical Center Savannah Georgia United States 31404
    47 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    48 Queen's Medical Center Honolulu Hawaii United States 96813
    49 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    50 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    51 Northwestern University Chicago Illinois United States 60611
    52 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    53 Rush University Medical Center Chicago Illinois United States 60612
    54 University of Illinois Chicago Illinois United States 60612
    55 Decatur Memorial Hospital Decatur Illinois United States 62526
    56 Crossroads Cancer Center Effingham Illinois United States 62401
    57 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    58 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    59 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    60 Advocate Christ Medical Center Oak Lawn Illinois United States 60453-2699
    61 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    62 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    63 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61114
    64 Memorial Medical Center Springfield Illinois United States 62781
    65 Carle Cancer Center Urbana Illinois United States 61801
    66 Saint Vincent Anderson Regional Hospital/Cancer Center Anderson Indiana United States 46016
    67 Elkhart General Hospital Elkhart Indiana United States 46515
    68 Radiation Oncology Associates PC Fort Wayne Indiana United States 46804
    69 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    70 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    71 Goshen Center for Cancer Care Goshen Indiana United States 46526
    72 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    73 IU Health Methodist Hospital Indianapolis Indiana United States 46202
    74 IU Health Central Indiana Cancer Centers-East Indianapolis Indiana United States 46219
    75 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana United States 46545
    76 Memorial Hospital of South Bend South Bend Indiana United States 46601
    77 McFarland Clinic PC - Ames Ames Iowa United States 50010
    78 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    79 University of Kansas Cancer Center Kansas City Kansas United States 66160
    80 Olathe Health Cancer Center Olathe Kansas United States 66061
    81 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    82 Salina Regional Health Center Salina Kansas United States 67401
    83 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    84 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    85 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    86 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    87 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    88 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    89 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    90 UM Upper Chesapeake Medical Center Bel Air Maryland United States 21014
    91 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
    92 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland United States 21061
    93 Holy Cross Hospital Silver Spring Maryland United States 20910
    94 Boston Medical Center Boston Massachusetts United States 02118
    95 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    96 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    97 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    98 University of Michigan - Brighton Center for Specialty Care Brighton Michigan United States 48116
    99 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    100 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    101 Henry Ford Hospital Detroit Michigan United States 48202
    102 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    103 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    104 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    105 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    106 William Beaumont Hospital - Troy Troy Michigan United States 48085
    107 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    108 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    109 Miller-Dwan Hospital Duluth Minnesota United States 55805
    110 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    111 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    112 University of Mississippi Medical Center Jackson Mississippi United States 39216
    113 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    114 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    115 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    116 North Kansas City Hospital Kansas City Missouri United States 64116
    117 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
    118 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    119 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    120 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    121 Washington University School of Medicine Saint Louis Missouri United States 63110
    122 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    123 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    124 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    125 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    126 Mercy Hospital Springfield Springfield Missouri United States 65804
    127 CoxHealth South Hospital Springfield Missouri United States 65807
    128 CHI Health Good Samaritan Kearney Nebraska United States 68847
    129 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    130 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    131 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    132 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    133 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    134 Virtua Memorial Mount Holly New Jersey United States 08060
    135 Sparta Cancer Treatment Center Sparta New Jersey United States 07871
    136 Virtua Voorhees Voorhees New Jersey United States 08043
    137 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    138 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    139 South Shore University Hospital Bay Shore New York United States 11706
    140 New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York United States 11215
    141 Roswell Park Cancer Institute Buffalo New York United States 14263
    142 Sands Cancer Center Canandaigua New York United States 14424
    143 Memorial Sloan Kettering Commack Commack New York United States 11725
    144 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
    145 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    146 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    147 Mount Sinai Union Square New York New York United States 10003
    148 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    149 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    150 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    151 Wilmot Cancer Institute Radiation Oncology at Greece Rochester New York United States 14606
    152 Highland Hospital Rochester New York United States 14620
    153 University of Rochester Rochester New York United States 14642
    154 Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York United States 10591
    155 State University of New York Upstate Medical University Syracuse New York United States 13210
    156 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    157 Atrium Health Stanly/LCI-Albemarle Albemarle North Carolina United States 28002
    158 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    159 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    160 Atrium Health Pineville/LCI-Pineville Charlotte North Carolina United States 28210
    161 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
    162 East Carolina University Greenville North Carolina United States 27834
    163 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    164 Atrium Health Union/LCI-Union Monroe North Carolina United States 28112
    165 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    166 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    167 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    168 Summa Health System - Akron Campus Akron Ohio United States 44304
    169 Cleveland Clinic Akron General Akron Ohio United States 44307
    170 Summa Health System - Barberton Campus Barberton Ohio United States 44203
    171 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    172 Geauga Hospital Chardon Ohio United States 44024
    173 Adena Regional Medical Center Chillicothe Ohio United States 45601
    174 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    175 Case Western Reserve University Cleveland Ohio United States 44106
    176 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    177 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    178 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    179 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
    180 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
    181 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    182 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    183 Summa Health Medina Medical Center Medina Ohio United States 44256
    184 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    185 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    186 University Hospitals Parma Medical Center Parma Ohio United States 44129
    187 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    188 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
    189 North Coast Cancer Care Sandusky Ohio United States 44870
    190 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
    191 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
    192 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    193 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    194 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    195 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    196 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    197 Providence Portland Medical Center Portland Oregon United States 97213
    198 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    199 UPMC Altoona Altoona Pennsylvania United States 16601
    200 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    201 Carlisle Regional Cancer Center Carlisle Pennsylvania United States 17015
    202 UPMC Hillman Cancer Center Erie Erie Pennsylvania United States 16505
    203 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
    204 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    205 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    206 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    207 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    208 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
    209 UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania United States 17050
    210 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
    211 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    212 UPMC Cancer Center-Natrona Heights Natrona Heights Pennsylvania United States 15065
    213 UPMC Jameson New Castle Pennsylvania United States 16105
    214 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    215 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    216 Temple University Hospital Philadelphia Pennsylvania United States 19140
    217 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    218 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    219 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
    220 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    221 UPMC Jefferson Regional Radiation Oncology Pittsburgh Pennsylvania United States 15236
    222 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
    223 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
    224 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
    225 UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania United States 15401
    226 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
    227 Reading Hospital West Reading Pennsylvania United States 19611
    228 Wexford Health and Wellness Pavilion Wexford Pennsylvania United States 15090
    229 AnMed Health Cancer Center Anderson South Carolina United States 29621
    230 Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina United States 29910
    231 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    232 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    233 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    234 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    235 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    236 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    237 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    238 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    239 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    240 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    241 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    242 University of Texas Medical Branch Galveston Texas United States 77555-0565
    243 M D Anderson Cancer Center Houston Texas United States 77030
    244 UTMB Cancer Center at Victory Lakes League City Texas United States 77573
    245 Covenant Medical Center-Lakeside Lubbock Texas United States 79410
    246 Intermountain Medical Center Murray Utah United States 84107
    247 Saint George Regional Medical Center Saint George Utah United States 84770
    248 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    249 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    250 Inova Fairfax Hospital Falls Church Virginia United States 22042
    251 Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia United States 23666
    252 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    253 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    254 Sentara Virginia Beach General Hospital Virginia Beach Virginia United States 23454
    255 Saint Francis Hospital Federal Way Washington United States 98003
    256 Tri-Cities Cancer Center Kennewick Washington United States 99336
    257 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    258 Skagit Regional Health Cancer Care Center Mount Vernon Washington United States 98274
    259 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    260 Spokane Valley Cancer Center-Mayfair Spokane Washington United States 99208
    261 Spokane Valley Cancer Center-Mission Spokane Washington United States 99216
    262 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
    263 West Virginia University Healthcare Morgantown West Virginia United States 26506
    264 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
    265 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    266 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    267 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    268 UW Cancer Center Johnson Creek Johnson Creek Wisconsin United States 53038
    269 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    270 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    271 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    272 Bay Area Medical Center Marinette Wisconsin United States 54143
    273 Marshfield Medical Center Marshfield Wisconsin United States 54449
    274 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    275 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    276 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    277 Drexel Town Square Health Center Oak Creek Wisconsin United States 53154
    278 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    279 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
    280 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    281 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    282 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    283 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    284 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    285 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
    286 Chinese University of Hong Kong-Prince of Wales Hospital Shatin Hong Kong China

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • NRG Oncology

    Investigators

    • Principal Investigator: Paul M Harari, NRG Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT01810913
    Other Study ID Numbers:
    • NCI-2013-00500
    • NCI-2013-00500
    • RTOG-1216
    • RTOG-1216
    • RTOG-1216
    • U10CA180868
    • U10CA021661
    • NCT04411121
    First Posted:
    Mar 14, 2013
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    No Results Posted as of Aug 17, 2022