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

NCT02135042 | Active Not Recruiting Phase 2

• 6 other identifiers: NRG-HN001NCI-2014-00635s16-00025RTOG-1305U10CA021661U10CA180868
• Study Type: interventional
• Target: 924
• Locations: 8 countries
• Sites: 213

Brief Summary

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 and shrink tumors. 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.

Conditions

EBV Infection; Stage II Nasopharyngeal Carcinoma AJCC v7; Stage III Nasopharyngeal Carcinoma AJCC v7; Stage IVA Nasopharyngeal Carcinoma AJCC v7; Stage IVB Nasopharyngeal Carcinoma AJCC v7

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS) (Detectable Plasma Epstein Barr virus [EBV] deoxyribonucleic acid [DNA] Cohort Phase II)

  Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided stratified log rank test. for stratification factors and concurrent cisplatin dose. A one-sided log rank test will be used to compare the PFS at a significance level of 0.1379.

  Up to 7 years

• Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III)

  Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided stratified log rank test. for stratification factors and concurrent cisplatin dose. The confidence interval approach will be used for the final analysis of OS.

  Up to 7 years

Secondary Outcomes (13)

• Time to distant metastasis (DM) (Phase II and III)

  Up to 7 years

• Time to local progression (Phase II and III)

  Up to 7 years

• Time to regional progression (Phase II and III)

  Up to 7 years

• Progression-free survival (PFS) (Undetectable Plasma EBV DNA Cohort Phase III)

  Up to 7 years

• Overall survival (OS) (Detectable Plasma EBV DNA Cohort Phase II)

  Up to 7 years

Study Arms (4)

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil)

ACTIVE COMPARATOR

Patients receive PF regimen comprising cisplatin IV over 60-180 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. Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.

Procedure: Bone Scan; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Fluorouracil; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment

Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel)

EXPERIMENTAL

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. Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.

Procedure: Bone Scan; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Gemcitabine Hydrochloride; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment

Phase II, Arm III (chemoradiation, cisplatin, fluorouracil)

ACTIVE COMPARATOR

Patients receive PF regimen as in Arm I of Phase II.Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.

Procedure: Bone Scan; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Fluorouracil; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment

Phase II, Arm IV (chemoradiation, observation)

EXPERIMENTAL

Patients undergo clinical observation. Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.

Procedure: Bone Scan; Drug: Cisplatin; Other: Clinical Observation; Procedure: Computed Tomography; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment

Interventions

Cisplatin DRUG

Given IV

Also known as: 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

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Clinical Observation OTHER

Undergo clinical observation

Also known as: observation

Phase II, Arm IV (chemoradiation, observation)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Laboratory Biomarker Analysis OTHER

Correlative studies

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: 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

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Phase I, Arm I (chemoradiation, cisplatin, fluorouracil); Phase I, Arm II (chemoradiation, gemcitabine, paclitaxel); Phase II, Arm III (chemoradiation, cisplatin, fluorouracil); Phase II, Arm IV (chemoradiation, observation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs 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
• Stage II-IVB disease (American Joint Committee on Cancer \[AJCC\], 7th edition \[ed.\]) 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 Ear, Nose, Throat specialist (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:
• Magnetic resonance imaging (MRI) of the nasopharynx and neck; or computed tomography (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
• To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:
• 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)
• 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
• Age \>= 18
• Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 21 days prior to registration)

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• NRG Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (213)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Kaiser Permanente Dublin

Dublin, California, 94568, United States

Location

Fresno Cancer Center

Fresno, California, 93720, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Cancer Center

Sacramento, California, 95823, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

Location

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, 80401, United States

Location

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States

Location

AdventHealth Parker

Parker, Colorado, 80138, United States

Location

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

McLaren Cancer Institute-Bay City

Bay City, Michigan, 48706, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

Location

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, 48346, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

McLaren Cancer Institute-Flint

Flint, Michigan, 48532, United States

Location

Singh and Arora Hematology Oncology PC

Flint, Michigan, 48532, United States

Location

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

Location

Mid-Michigan Physicians-Lansing

Lansing, Michigan, 48912, United States

Location

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

Location

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, 48446, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

McLaren-Port Huron

Port Huron, Michigan, 48060, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

Location

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Saint Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

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

New York, New York, 10032, United States

Location

New York Proton Center

New York, New York, 10035, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Memorial Sloan Kettering Sleepy Hollow

Sleepy Hollow, New York, 10591, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, 44906, United States

Location

North Coast Cancer Care

Sandusky, Ohio, 44870, United States

Location

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, 84003, United States

Location

Sandra L Maxwell Cancer Center

Cedar City, Utah, 84720, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Riverton Hospital

Riverton, Utah, 84065, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

Saint George Regional Medical Center

St. George, Utah, 84770, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

Aspirus Cancer Care-Antigo-Volm Cancer Center

Antigo, Wisconsin, 54409, United States

Location

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Aspirus Cancer Care-Wausau

Wausau, Wisconsin, 54401, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

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

Montreal, Quebec, H3H 2R9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Zhongshan Hospital Fudan University

Guangdong Province, Shanghai Municipality, 200032, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Location

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Location

Chinese University of Hong Kong-Prince of Wales Hospital

Shatin, Hong Kong

Location

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Hospital-Lin Kou Medical Center

Taoyuan, 33333, Taiwan

Location

Related Publications (1)

• Colevas AD, Cmelak AJ, Pfister DG, Spencer S, Adkins D, Birkeland AC, Brizel DM, Busse PM, Caudell JJ, Durm G, Fakhry C, Galloway T, Geiger JL, Gillison ML, Glastonbury C, Haddad RI, Hicks WL, Hitchcock YJ, Jimeno A, Juloori A, Kase M, Leizman D, Maghami E, Mell LK, Mittal BB, Pinto HA, Price K, Rocco JW, Rodriguez CP, Schwartz D, Shah JP, Sher D, John MS, Wang H, Weinstein G, Worden F, Bruce JY, Yom SS, Zhen W, Montgomery S, Darlow SD. NCCN Guidelines(R) Insights: Head and Neck Cancers, Version 2.2025. J Natl Compr Canc Netw. 2025 Feb;23(2):2-11. doi: 10.6004/jnccn.2025.0007.

  PMID: 39938471 DERIVED

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Nasopharyngeal Carcinoma

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Watchful Waiting; Observation; Fluorouracil; dehydroftorafur; Gemcitabine; Radiotherapy, Intensity-Modulated; Magnetic Resonance Spectroscopy; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Nancy Y Lee

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: July 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (197); SG (1); PR (1); CN (2); AU (1); TW (2); CA (7); HK (2)