Clinical Trial - NCT02135042

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

Recruiting

Sponsor: NRG Oncology

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02135042

Protocol Info

Short Description: Phase II/III of Nasopharyngeal Carcinoma Based on Epstein Barr Virus (EBV) DNA
Long Description: NRG-HN001: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA
MGH Status: Open
Sponsor: NRG Oncology
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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.
Condition Title Intervention Phase
Epstein-Barr Virus Infection Stage II Nasopharyngeal Carcinoma Stage III Nasopharyngeal Carcinoma Stage IVA Nasopharyngeal Carcinoma Stage IVB Nasopharyngeal Carcinoma Cisplatin Clinical Observation Fluorouracil Gemcitabine Hydrochloride Intensity-Modulated Radiation Therapy Laboratory Biomarker Analysis Paclitaxel Quality-of-Life Assessment Phase 2/Phase 3
Study Type Interventional
Official Title Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

Primary Outcome Measures

Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II) [Time Frame: Up to 7 years] [Designated as safety issue: ]


Secondary Outcome Measures

Changes in pure tone audiometry (Phase II and III) [Time Frame: Baseline to up to 1 year] [Designated as safety issue: ]

Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III) [Time Frame: Baseline to up to 24 months] [Designated as safety issue: ]

Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III) [Time Frame: Baseline to up to 24 months] [Designated as safety issue: ]

Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III) [Time Frame: Baseline to up to 24 months] [Designated as safety issue: ]

Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Incidence of acute grade 3-5 adverse events (Phase II and III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Incidence of death (Phase II and III) [Time Frame: Up to 30 days of end of protocol treatment] [Designated as safety issue: ]

Incidence of late grade 3-5 adverse events (Phase II and III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

OS (Detectable Plasma EBV DNA Cohort Phase II) [Time Frame: Up to 7 years] [Designated as safety issue: ]

PFS (Undetectable Plasma EBV DNA Cohort Phase III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Time to distant metastasis (DM) (Phase II and III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Time to local progression (Phase II and III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Time to regional progression (Phase II and III) [Time Frame: Up to 7 years] [Designated as safety issue: ]

Estimated Enrollment: 758
Study Start Date: April 2014
Estimated Study Completion Date: July 2026
Estimated Primary Completion Date: July 2021
Arms Assigned Interventions

Active Comparator: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.
Other:Quality-of-Life Assessment
Ancillary studies

Experimental: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.
Drug:Paclitaxel
Given IV

Active Comparator:Arm III (chemoradiation, cisplatin, fluorouracil)

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

Experimental:Arm IV (chemoradiation, observation)

Patients undergo clinical observation.
Other:Clinical Observation
Undergo clinical observation

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
  • Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration
  • 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 with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan 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, abdomen, and/or pelvis or a total body positron emission tomography (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
  • 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) or 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
  • 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02135042

Locations

  • United States, Alabama
    • University of Alabama at Birmingham Cancer Center Birmingham, Alabama, United States, 35233
    • The Kirklin Clinic at Acton Road Birmingham, Alabama, United States, 35243
  • United States, Arizona
    • Banner University Medical Center - Tucson Tucson, Arizona, United States, 85719
  • United States, California
    • Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California, United States, 95603
    • Alta Bates Summit Medical Center-Herrick Campus Berkeley, California, United States, 94704
    • Mills-Peninsula Medical Center Burlingame, California, United States, 94010
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California, United States, 95682
    • City of Hope Comprehensive Cancer Center Duarte, California, United States, 91010
    • Kaiser Permanente Dublin Dublin, California, United States, 94568
    • Fresno Cancer Center Fresno, California, United States, 93720
    • UC San Diego Moores Cancer Center La Jolla, California, United States, 92093
    • Memorial Medical Center Modesto, California, United States, 95355
    • Kaiser Permanente Oakland-Broadway Oakland, California, United States, 94611
    • UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California, United States, 92868
    • Palo Alto Medical Foundation Health Care Palo Alto, California, United States, 94301
    • Stanford Cancer Institute Palo Alto Palo Alto, California, United States, 94304
    • Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California, United States, 95670
    • Rohnert Park Cancer Center Rohnert Park, California, United States, 94928
    • Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California, United States, 95661
    • The Permanente Medical Group-Roseville Radiation Oncology Roseville, California, United States, 95678
    • Sutter Medical Center Sacramento Sacramento, California, United States, 95816
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • South Sacramento Cancer Center Sacramento, California, United States, 95823
    • California Pacific Medical Center-Pacific Campus San Francisco, California, United States, 94115
    • UCSF Medical Center-Mount Zion San Francisco, California, United States, 94115
    • Kaiser Permanente Medical Center - Santa Clara Santa Clara, California, United States, 95051
    • City of Hope South Pasadena South Pasadena, California, United States, 91030
    • Kaiser Permanente Cancer Treatment Center South San Francisco, California, United States, 94080
    • Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California, United States, 94086
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville, California, United States, 95687
  • United States, Colorado
    • North Colorado Medical Center Greeley, Colorado, United States, 80631
    • McKee Medical Center Loveland, Colorado, United States, 80539
    • Parker Adventist Hospital Parker, Colorado, United States, 80138
    • SCL Health Lutheran Medical Center Wheat Ridge, Colorado, United States, 80033
  • United States, Connecticut
    • Yale University New Haven, Connecticut, United States, 06520
  • United States, Delaware
    • Helen F Graham Cancer Center Newark, Delaware, United States, 19713
    • Christiana Care Health System-Christiana Hospital Newark, Delaware, United States, 19718
  • United States, Florida
    • Baptist MD Anderson Cancer Center Jacksonville, Florida, United States, 32207
    • Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Georgia
    • Emory Proton Therapy Center Atlanta, Georgia, United States, 30308
    • Emory University Hospital Midtown Atlanta, Georgia, United States, 30308
    • Emory University Hospital/Winship Cancer Institute Atlanta, Georgia, United States, 30322
    • Emory Saint Joseph's Hospital Atlanta, Georgia, United States, 30342
  • United States, Hawaii
    • The Cancer Center of Hawaii-Pali Momi 'Aiea, Hawaii, United States, 96701
    • Queen's Medical Center Honolulu, Hawaii, United States, 96813
    • The Cancer Center of Hawaii-Liliha Honolulu, Hawaii, United States, 96817
  • United States, Idaho
    • Saint Alphonsus Cancer Care Center-Boise Boise, Idaho, United States, 83706
  • United States, Illinois
    • Northwestern University Chicago, Illinois, United States, 60611
    • John H Stroger Jr Hospital of Cook County Chicago, Illinois, United States, 60612
    • Cancer Care Specialists of Illinois - Decatur Decatur, Illinois, United States, 62526
    • Decatur Memorial Hospital Decatur, Illinois, United States, 62526
    • Crossroads Cancer Center Effingham, Illinois, United States, 62401
    • Memorial Medical Center Springfield, Illinois, United States, 62781
    • Carle Cancer Center Urbana, Illinois, United States, 61801
  • United States, Indiana
    • Memorial Hospital of South Bend South Bend, Indiana, United States, 46601
  • United States, Iowa
    • Iowa Methodist Medical Center Des Moines, Iowa, United States, 50309
    • University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa, United States, 52242
  • United States, Kansas
    • Ascension Via Christi Hospitals Wichita Wichita, Kansas, United States, 67214
    • Wesley Medical Center Wichita, Kansas, United States, 67214
  • United States, Maryland
    • Greater Baltimore Medical Center Baltimore, Maryland, United States, 21204
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Tufts Medical Center Boston, Massachusetts, United States, 02111
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Boston Medical Center Boston, Massachusetts, United States, 02118
  • United States, Michigan
    • Saint Joseph Mercy Hospital Ann Arbor, Michigan, United States, 48106
    • University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
    • McLaren Cancer Institute-Bay City Bay City, Michigan, United States, 48706
    • Henry Ford Cancer Institute-Downriver Brownstown, Michigan, United States, 48183
    • McLaren Cancer Institute-Clarkston Clarkston, Michigan, United States, 48346
    • Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan, United States, 48038
    • Wayne State University/Karmanos Cancer Institute Detroit, Michigan, United States, 48201
    • Henry Ford Hospital Detroit, Michigan, United States, 48202
    • Weisberg Cancer Treatment Center Farmington Hills, Michigan, United States, 48334
    • McLaren Cancer Institute-Flint Flint, Michigan, United States, 48532
    • Singh and Arora Hematology Oncology PC Flint, Michigan, United States, 48532
    • McLaren-Greater Lansing Lansing, Michigan, United States, 48910
    • Mid-Michigan Physicians-Lansing Lansing, Michigan, United States, 48912
    • Sparrow Hospital Lansing, Michigan, United States, 48912
    • McLaren Cancer Institute-Lapeer Region Lapeer, Michigan, United States, 48446
    • Saint Mary Mercy Hospital Livonia, Michigan, United States, 48154
    • McLaren Cancer Institute-Macomb Mount Clemens, Michigan, United States, 48043
    • McLaren Cancer Institute-Central Michigan Mount Pleasant, Michigan, United States, 48858
    • McLaren Cancer Institute-Northern Michigan Petoskey, Michigan, United States, 49770
    • Saint Joseph Mercy Oakland Pontiac, Michigan, United States, 48341
    • McLaren-Port Huron Port Huron, Michigan, United States, 48060
    • Henry Ford West Bloomfield Hospital West Bloomfield, Michigan, United States, 48322
  • United States, Minnesota
    • Fairview Ridges Hospital Burnsville, Minnesota, United States, 55337
    • Unity Hospital Fridley, Minnesota, United States, 55432
    • Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota, United States, 55109
    • Hennepin County Medical Center Minneapolis, Minnesota, United States, 55415
    • Mayo Clinic Rochester, Minnesota, United States, 55905
    • Regions Hospital Saint Paul, Minnesota, United States, 55101
    • Rice Memorial Hospital Willmar, Minnesota, United States, 56201
  • United States, Missouri
    • Saint Francis Medical Center Cape Girardeau, Missouri, United States, 63703
    • Siteman Cancer Center at West County Hospital Creve Coeur, Missouri, United States, 63141
    • Delbert Day Cancer Institute at PCRMC Rolla, Missouri, United States, 65401
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Siteman Cancer Center-South County Saint Louis, Missouri, United States, 63129
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
    • Siteman Cancer Center at Saint Peters Hospital Saint Peters, Missouri, United States, 63376
    • CoxHealth South Hospital Springfield, Missouri, United States, 65807
  • United States, Nebraska
    • Nebraska Methodist Hospital Omaha, Nebraska, United States, 68114
  • United States, Nevada
    • Renown Regional Medical Center Reno, Nevada, United States, 89502
    • Saint Mary's Regional Medical Center Reno, Nevada, United States, 89503
  • United States, New Jersey
    • Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey, United States, 07920
    • Memorial Sloan Kettering Monmouth Middletown, New Jersey, United States, 07748
    • Memorial Sloan Kettering Bergen Montvale, New Jersey, United States, 07645
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08903
    • Rutgers New Jersey Medical School Newark, New Jersey, United States, 07101
  • United States, New York
    • Montefiore Medical Center-Einstein Campus Bronx, New York, United States, 10461
    • Montefiore Medical Center - Moses Campus Bronx, New York, United States, 10467
    • New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York, United States, 11215
    • Maimonides Medical Center Brooklyn, New York, United States, 11219
    • Memorial Sloan Kettering Commack Commack, New York, United States, 11725
    • Memorial Sloan Kettering Westchester Harrison, New York, United States, 10604
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York, United States, 10016
    • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York, United States, 10032
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
    • University of Rochester Rochester, New York, United States, 14642
    • Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow, New York, United States, 10591
    • Memorial Sloan Kettering Nassau Uniondale, New York, United States, 11553
  • United States, Ohio
    • Cleveland Clinic Akron General Akron, Ohio, United States, 44307
    • Geauga Hospital Chardon, Ohio, United States, 44024
    • University of Cincinnati/Barrett Cancer Center Cincinnati, Ohio, United States, 45219
    • Case Western Reserve University Cleveland, Ohio, United States, 44106
    • Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio, United States, 44111
    • Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195
    • Ohio State University Comprehensive Cancer Center Columbus, Ohio, United States, 43210
    • Mercy Cancer Center-Elyria Elyria, Ohio, United States, 44035
    • Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio, United States, 44906
    • North Coast Cancer Care Sandusky, Ohio, United States, 44870
    • Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio, United States, 44136
    • ProMedica Flower Hospital Sylvania, Ohio, United States, 43560
    • University Pointe West Chester, Ohio, United States, 45069
    • Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio, United States, 44691
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
    • Mercy Hospital Oklahoma City Oklahoma City, Oklahoma, United States, 73120
  • United States, Oregon
    • Legacy Mount Hood Medical Center Gresham, Oregon, United States, 97030
    • Legacy Good Samaritan Hospital and Medical Center Portland, Oregon, United States, 97210
  • United States, Pennsylvania
    • Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania, United States, 19317
    • Geisinger Medical Center Danville, Pennsylvania, United States, 17822
    • Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania, United States, 17837
    • Reading Hospital West Reading, Pennsylvania, United States, 19611
    • Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania, United States, 18711
  • United States, South Carolina
    • Prisma Health Cancer Institute - Faris Greenville, South Carolina, United States, 29605
    • Saint Francis Cancer Center Greenville, South Carolina, United States, 29607
    • Prisma Health Cancer Institute - Eastside Greenville, South Carolina, United States, 29615
    • Prisma Health Cancer Institute - Greer Greer, South Carolina, United States, 29650
    • Gibbs Cancer Center-Pelham Greer, South Carolina, United States, 29651
    • Prisma Health Cancer Institute - Seneca Seneca, South Carolina, United States, 29672
    • Spartanburg Medical Center Spartanburg, South Carolina, United States, 29303
    • Prisma Health Cancer Institute - Spartanburg Spartanburg, South Carolina, United States, 29307
  • United States, Texas
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • M D Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Utah
    • American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah, United States, 84003
    • Sandra L Maxwell Cancer Center Cedar City, Utah, United States, 84720
    • Intermountain Medical Center Murray, Utah, United States, 84107
    • Utah Valley Regional Medical Center Provo, Utah, United States, 84604
    • Riverton Hospital Riverton, Utah, United States, 84065
    • Dixie Medical Center Regional Cancer Center Saint George, Utah, United States, 84770
    • Utah Cancer Specialists-Salt Lake City Salt Lake City, Utah, United States, 84106
  • United States, Virginia
    • Inova Schar Cancer Institute Fairfax, Virginia, United States, 22031
    • Inova Fairfax Hospital Falls Church, Virginia, United States, 22042
    • Naval Medical Center - Portsmouth Portsmouth, Virginia, United States, 23708-2197
  • United States, Washington
    • Legacy Salmon Creek Hospital Vancouver, Washington, United States, 98686
  • United States, Wisconsin
    • HSHS Sacred Heart Hospital Eau Claire, Wisconsin, United States, 54701
    • Gundersen Lutheran Medical Center La Crosse, Wisconsin, United States, 54601
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Marshfield Medical Center Marshfield, Wisconsin, United States, 54449
    • Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
    • Marshfield Clinic-Minocqua Center Minocqua, Wisconsin, United States, 54548
    • Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin, United States, 54868
    • Saint Michael's Hospital Stevens Point, Wisconsin, United States, 54481
    • Diagnostic and Treatment Center Weston, Wisconsin, United States, 54476
  • Australia, Victoria
    • Peter MacCallum Cancer Centre Melbourne, Victoria, Australia, 3000
  • Canada, Alberta
    • Tom Baker Cancer Centre Calgary, Alberta, Canada, T2N 4N2
    • Cross Cancer Institute Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, Ontario
    • London Regional Cancer Program London, Ontario, Canada, N6A 4L6
    • University Health Network-Princess Margaret Hospital Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • McGill University Department of Oncology Montreal, Quebec, Canada, H2W 1S6
    • The Research Institute of the McGill University Health Centre (MUHC) Montreal, Quebec, Canada, H3H 2R9
    • Jewish General Hospital Montreal, Quebec, Canada, H3T 1E2
  • China, Hong Kong
    • Chinese University of Hong Kong-Prince of Wales Hospital Shatin, Hong Kong, China,
  • China, Shanghai
    • Zhongshan Hospital Fudan University Guangdong Province, Shanghai, China, 200032
  • China,
    • Sun Yat-sen University Cancer Center Guangzhou, , China, 510060
  • Hong Kong,
    • Pamela Youde Nethersole Eastern Hospital Chai Wan, , Hong Kong,
  • Puerto Rico,
    • Centro Comprensivo de Cancer de UPR San Juan, , Puerto Rico, 00927
  • Singapore,
    • National Cancer Centre Singapore, , Singapore, 169610
  • Taiwan,
    • National Taiwan University Hospital Taipei, , Taiwan, 100
    • Chang Gung Hospital-Lin Kou Medical Center Taoyuan, , Taiwan, 33333

Sponsors and Collaborators

NRG Oncology

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02135042
Other Study ID Numbers: NCI-2014-00635
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Epstein-Barr Virus Infections

Carcinoma

Nasopharyngeal Carcinoma

Virus Diseases

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Fluorouracil

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020