Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

NCT ID: NCT02135042

Last Updated: 2025-11-19

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

685 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-21

Study Completion Date

2031-02-28

Brief Summary

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There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine whether substituting adjuvant concurrent high dose cisplatin (CDDP) and fluorouracil (5-FU) with gemcitabine (gemcitabine hydrochloride) and paclitaxel will result in superior progression-free survival. (Detectable Plasma Epstein Barr Virus \[EBV\] Deoxyribonucleic Acid \[DNA\] Cohort randomized Phase II) II. To determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in non-inferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy. (Undetectable Plasma EBV DNA Cohort Phase III)

SECONDARY OBJECTIVES:

I. Time to distant metastasis. (Randomized Phase II and Phase III) II. Time to local progression. (Randomized Phase II and Phase III) III. Time to regional progression. (Randomized Phase II and Phase III) IV. Progression-free survival (Undetectable Cohort). V. Overall survival (Detectable Cohort). VI. Acute and late toxicity profiles based on clinician-reported Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4. (Randomized Phase II and Phase III) VII. Death during or within 30 days of end of protocol treatment. (Randomized Phase II and Phase III) VIII. Quality of life (general and physical well-being). (Randomized Phase II and Phase III) IX. Quality of life (hearing). (Randomized Phase II and Phase III) X. Quality of life (peripheral neuropathy). (Randomized Phase II and Phase III) XI. Cost effectiveness. (Randomized Phase II and Phase III)

OUTLINE:

Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6.5 weeks and receive low-dose cisplatin intravenously (IV) over 30-60 minutes once weekly during IMRT. Beginning 1 week after chemoradiation, plasma samples are collected for EBV DNA analysis.

PHASE II: Patients with detectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms.

ARM I: Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PHASE III:

Patients with undetectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms.

ARM III: Patients receive PF regimen as in Arm I.

ARM IV: Patients undergo clinical observation.

After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

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Epstein-Barr Virus Infection Stage II Nasopharyngeal Carcinoma Stage III Nasopharyngeal Carcinoma Stage IVA Nasopharyngeal Carcinoma Stage IVB Nasopharyngeal Carcinoma

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 I (chemoradiation, cisplatin, fluorouracil)

Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Given IV

Fluorouracil

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel)

Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given IV

Gemcitabine Hydrochloride

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Paclitaxel

Intervention Type DRUG

Given IV

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm III (chemoradiation, cisplatin, fluorouracil)

Patients receive PF regimen as in Arm I of Phase II.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Given IV

Fluorouracil

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm IV (chemoradiation, observation)

Patients undergo clinical observation.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given IV

Clinical Observation

Intervention Type OTHER

Undergo clinical observation

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Cisplatin

Given IV

Intervention Type DRUG

Clinical Observation

Undergo clinical observation

Intervention Type OTHER

Fluorouracil

Given IV

Intervention Type DRUG

Gemcitabine Hydrochloride

Given IV

Intervention Type DRUG

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Paclitaxel

Given IV

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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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 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil 5-Fluracil 5-FU AccuSite Actino-Hermal Adrucil Arumel Cytosafe Efudex Efurix Fiverocil Fluoro Uracil Fluoroplex Fluouracil Flurablastin Fluracedyl Fluracil Fluril Fluroblastin Flurox Ribofluor Ro 2-9757 Ro-2-9757 Timazin dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011 IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
* Sites are required to complete Step 1 registration before submitting specimens for EBV DNA analysis.

* Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration (see Section 10.2 for details of specimen submission).
* For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs (listed on the EBV DNA Testing Specimen Transmittal form) within 28 days prior to Step 1 registration: that test result can be used for eligibility without the need for re-testing. To use this test result for eligibility, the central lab must enter the test result through the pathology portal, and the site must follow the instructions in Section 5.4.
* Stage II-IVB disease (AJCC, 7th ed.) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:

* History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or ENT, which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration;
* Evaluation of tumor extent required within 28 days prior to registration:
* MRI of the nasopharynx and neck; or CT of the nasopharynx and neck with ≤ 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement).

Note: If a treatment planning CT scan is used, it must be with ≤ 3 mm contiguous slices with contrast and be read by a radiologist.

Please refer to section 6.3.2 for MRI requirement for target delineation.

* To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:

1. a CT scan with contrast of the chest and abdomen (required), and the pelvis (optional), or a total body PET/CT scan (non-contrast PET/CT is acceptable);
2. a bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan).
* Zubrod performance status 0-1 within 21 days prior to registration
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* 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 ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
* Alkaline phosphatase ≤ 1.5 x institutional ULN
* Serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
* Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
* Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

Exclusion Criteria

* Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
* ≥ Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
* Severe, active co-morbidity, defined as follows:

* Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy
* Unstable angina and/or uncontrolled congestive heart failure within the past 6 months
* Myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
* Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that 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.
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Prior allergic reaction to the study drug(s) involved in this protocol
* Patients with undetectable pre-treatment plasma EBV DNA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NRG Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Lee

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

The Kirklin Clinic at Acton Road

Birmingham, Alabama, United States

Site Status

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Mills-Peninsula Medical Center

Burlingame, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente Dublin

Dublin, California, United States

Site Status

Fresno Cancer Center

Fresno, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

South Sacramento Cancer Center

Sacramento, California, United States

Site Status

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Site Status

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

City of Hope South Pasadena

South Pasadena, California, United States

Site Status

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Site Status

SCL Health Cancer Centers of Colorado - Lutheran Medical Center

Golden, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Parker Adventist Hospital

Parker, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Emory Proton Therapy Center

Atlanta, Georgia, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

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Greater Baltimore Medical Center

Baltimore, Maryland, United States

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Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Site Status

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Site Status

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

Site Status

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

Site Status

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

McLaren-Port Huron

Port Huron, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

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North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

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Regions Hospital

Saint Paul, Minnesota, United States

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Rice Memorial Hospital

Willmar, Minnesota, United States

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Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

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CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status

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

New York, New York, United States

Site Status

New York Proton Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Memorial Sloan Kettering Sleepy Hollow

Sleepy Hollow, New York, United States

Site Status

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status

Geauga Hospital

Chardon, Ohio, United States

Site Status

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Saint Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Saint George Regional Medical Center

St. George, Utah, United States

Site Status

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status

Marshfield Medical Center

Marshfield, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status

Diagnostic and Treatment Center

Weston, Wisconsin, United States

Site Status

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

London Regional Cancer Program

London, Ontario, Canada

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

McGill University Department of Oncology

Montreal, Quebec, Canada

Site Status

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, Hong Kong, China

Site Status

Zhongshan Hospital Fudan University

Guangdong Province, Shanghai Municipality, China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status

Pamela Youde Nethersole Eastern Hospital

Chai Wan, , Hong Kong

Site Status

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Hospital-Lin Kou Medical Center

Taoyuan District, , Taiwan

Site Status

Countries

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United States Australia Canada China Hong Kong Puerto Rico Singapore Taiwan

Other Identifiers

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NCI-2014-00635

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-HN001

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-HN001

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA021661

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-HN001

Identifier Type: -

Identifier Source: org_study_id

NCT02179164

Identifier Type: -

Identifier Source: nct_alias

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