AzTrials
AzTrials

EBV InfectionPhase 2/3NCT02135042

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

A Phase 2/3 study testing Bone Scan, Cisplatin and Clinical Observation in people with EBV Infection and Stage II Nasopharyngeal Carcinoma AJCC v7, run by NRG Oncology at 213 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bone Scan, Cisplatin and Clinical Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
924 participants
Where
213 sitesin 8 countries
Study dates
1 Jul 2014to 1 Jan 2034
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Platelets >= 100,000 cells/mm^3 (within 21 days prior to registration)
  • Hemoglobin >= 8.0 g/dl (within 21 days prior to registration) (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) (within 21 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x institutional ULN (within 21 days prior to registration)
  • Alkaline phosphatase =< 1.5 x institutional ULN (within 21 days prior to registration)
  • 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 (within 21 days prior to registration)
  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

213 sites in 8 countries.

213 sites in 8 countries

United States197 sites

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • The Kirklin Clinic at Acton Road

    Birmingham, Alabama, 35243

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology PC

    Flint, Michigan, 48532

  • Fresno Cancer Center

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado, 80401

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • Mid-Michigan Physicians-Lansing

    Lansing, Michigan, 48912

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Memorial Medical Center

    Modesto, California, 95355

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • McLaren Cancer Institute-Central Michigan

    Mount Pleasant, Michigan, 48858

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

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

    New York, New York, 10032

  • New York Proton Center

    New York, New York, 10035

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • AdventHealth Parker

    Parker, Colorado, 80138

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • McLaren-Port Huron

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Riverton Hospital

    Riverton, Utah, 84065

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Memorial Sloan Kettering Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint George Regional Medical Center

    St. George, Utah, 84770

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Aspirus Cancer Care-Wausau

    Wausau, Wisconsin, 54401

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Intermountain Health Lutheran Hospital

    Wheat Ridge, Colorado, 80401

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

Other trials in United States

Canada7 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

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

    Montreal, Quebec, H3H 2R9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

China2 sites

  • Zhongshan Hospital Fudan University

    Guangdong Province, Shanghai Municipality, 200032

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

Other trials in China

Hong Kong2 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

  • Chinese University of Hong Kong-Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Hospital-Lin Kou Medical Center

    Taoyuan, 33333

Other trials in Taiwan

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

Puerto Rico1 site

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

Other trials in Puerto Rico

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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 to 7 weeks and receive low-dose cisplatin intravenously (IV) over 30-60 minutes or high-dose cisplatin IV over 3 hours 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 60-180 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.

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.

Patients undergo computed tomography (CT) scan, magnetic resonance imaging, (MRI) positron emission tomography (PET) scan, and bone scan throughout the study.

Being tested
Bone Scan, Cisplatin, Clinical Observation, Computed Tomography, Fluorouracil
Medical subject headings
Epstein-Barr Virus Infections, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Clinical ObservationOther

    Also called observation

    Undergo clinical observation

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02135042
Study groupRoleWhat they receive
Phase I, Arm I (chemoradiation, cisplatin, fluorouracil)Active comparatorPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: 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 comparatorPatients receive PF regimen as in Arm I of Phase II.Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.
Receives: 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)ExperimentalPatients undergo clinical observation. Patients undergo CT scan, MRI,PET scan, and bone scan throughout the study.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 7 years

  2. 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.

    Measured: Up to 7 years

Secondary outcomes (13)

  1. Time to distant metastasis (DM) (Phase II and III)

    The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.

    Measured: Up to 7 years

  2. Time to local progression (Phase II and III)

    The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.

    Measured: Up to 7 years

  3. Time to regional progression (Phase II and III)

    Defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.

    Measured: Up to 7 years

  4. Progression-free survival (PFS) (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.

    Measured: Up to 7 years

  5. Overall survival (OS) (Detectable Plasma EBV 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.

    Measured: Up to 7 years

  6. Incidence of acute grade 3-5 adverse events (Phase II and III)

    Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.

    Measured: Up to 7 years

  7. Incidence of late grade 3-5 adverse events (Phase II and III)

    Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.

    Measured: Up to 7 years

  8. Incidence of death (Phase II and III)

    Incidence of death will be determined.

    Measured: Up to 30 days of end of protocol treatment

  9. Changes in pure tone audiometry (Phase II and III)

    Correlation between categorical measures will be summarized by odds ratios, chi-square tests, and associated measures. Adjusted correlation may be derived from analysis of covariance (ANCOVA) models or derived directly using nonparametric analysis of variance (ANOVA) models if normality assumption is violated. Correlations between HHIE-S PRO scores and PTA and FACT-NP hearing, and PTA will be compared as dependent statistics

    Measured: Baseline to up to 1 year

  10. Changes in quality of life (QOL) (general and physical well-being) (Phase II and III)

    Will be assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP). Changes in patient reported outcome (PRO) scores will be correlated to clearance or non-clearance of EBV titers. Descriptive statistics derived from FACT-NP will be used to enrich the understanding of QOL as it pertains to the 2 phase III arms of observation versus additional adjuvant chemotherapy. Univariable and multivariable analysis will be performed using the Cox proportional hazards model for OS and distant metastasis. Pearson correlation will be estimated between general and physical well-being. QOL measures and change from baseline will be correlated to EBV DNA.

    Measured: Baseline to up to 24 months

  11. Changes in quality of life (QOL) (hearing) (Phase II and III)

    Will be assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S). QOL analysis including overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Overall and nasopharyngeal-specific QOL, hearing QOL (FACT-NP hearing domain, HHIE-S scores), peripheral neuropathy QOL over the short and long term and pure-tone audiometry (PTA) scores will be compared using a two sample independent t test and paired t test if the comparison is within the experimental arm between different time points.

    Measured: Baseline to up to 24 months

  12. Changes in quality of life (QOL) (peripheral neuropathy) as assessed by the Functional Assessment of Cancer Therapy (FACT)-Taxane (Phase II and III)

    Changes in QOL (peripheral neuropathy) will be assessed by the Functional Assessment of Cancer Therapy (FACT)-Taxane.

    Measured: Baseline to up to 24 months

  13. Cost effectiveness as assessed by the health-related quality of life (QOL) (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III)

    Incremental cost effectiveness ratios will be compared to determine the probability of cost effectiveness of various interventions, with sensitivity analyses to identify model weaknesses. The expected value of perfect information will be determined to delimit the upper boundary for cost-effective future investment in this area of research.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2014 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
924 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135042
Sponsor's protocol ID
NRG-HN001
Other IDs
NCI-2014-00635, s16-00025, RTOG-1305, NRG-HN001, NRG-HN001, U10CA021661, U10CA180868
Status last verified
Oct 2026
First submitted
7 May 2014
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39938471

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bone Scan, Cisplatin and Clinical Observation in people with EBV Infection and Stage II Nasopharyngeal Carcinoma AJCC v7, run by NRG Oncology at 213 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in United States, Canada, China, Hong Kong, Taiwan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (Detectable Plasma Epstein Barr virus [EBV] deoxyribonucleic acid [DNA] Cohort Phase II) (time frame: Up to 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02135042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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