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Brief Title: Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
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)
Study ID: NCT02135042
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. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To determine whether substituting adjuvant concurrent high dose cisplatin (CDDP) and fluorouracil (5-FU) with gemcitabine (gemcitabine hydrochloride) and paclitaxel will result in superior progression-free survival. (Detectable Plasma Epstein Barr Virus \[EBV\] Deoxyribonucleic Acid \[DNA\] Cohort randomized Phase II) II. To determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in non-inferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy. (Undetectable Plasma EBV DNA Cohort Phase III) SECONDARY OBJECTIVES: I. Time to distant metastasis. (Randomized Phase II and Phase III) II. Time to local progression. (Randomized Phase II and Phase III) III. Time to regional progression. (Randomized Phase II and Phase III) IV. Progression-free survival (Undetectable Cohort). V. Overall survival (Detectable Cohort). VI. Acute and late toxicity profiles based on clinician-reported Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4. (Randomized Phase II and Phase III) VII. Death during or within 30 days of end of protocol treatment. (Randomized Phase II and Phase III) VIII. Quality of life (general and physical well-being). (Randomized Phase II and Phase III) IX. Quality of life (hearing). (Randomized Phase II and Phase III) X. Quality of life (peripheral neuropathy). (Randomized Phase II and Phase III) XI. Cost effectiveness. (Randomized Phase II and Phase III) OUTLINE: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6.5 weeks and receive low-dose cisplatin intravenously (IV) over 30-60 minutes once weekly during IMRT. Beginning 1 week after chemoradiation, plasma samples are collected for EBV DNA analysis. PHASE II: Patients with detectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms. ARM I: Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. PHASE III: Patients with undetectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms. ARM III: Patients receive PF regimen as in Arm I. ARM IV: Patients undergo clinical observation. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
The Kirklin Clinic at Acton Road, Birmingham, Alabama, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
Mills-Peninsula Medical Center, Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Kaiser Permanente Dublin, Dublin, California, United States
Fresno Cancer Center, Fresno, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Memorial Medical Center, Modesto, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Palo Alto Medical Foundation Health Care, Palo Alto, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Rohnert Park Cancer Center, Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
South Sacramento Cancer Center, Sacramento, California, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States
Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, United States
SCL Health Cancer Centers of Colorado - Lutheran Medical Center, Golden, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Yale University, New Haven, Connecticut, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory Proton Therapy Center, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Northwestern University, Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
McLaren Cancer Institute-Bay City, Bay City, Michigan, United States
Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States
Saint Joseph Mercy Canton, Canton, Michigan, United States
McLaren Cancer Institute-Clarkston, Clarkston, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
McLaren Cancer Institute-Flint, Flint, Michigan, United States
Singh and Arora Hematology Oncology PC, Flint, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing, Lansing, Michigan, United States
Mid-Michigan Physicians-Lansing, Lansing, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
McLaren Cancer Institute-Lapeer Region, Lapeer, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
McLaren Cancer Institute-Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute-Central Michigan, Mount Pleasant, Michigan, United States
McLaren Cancer Institute-Northern Michigan, Petoskey, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
McLaren-Port Huron, Port Huron, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Saint Mary's Regional Medical Center, Reno, Nevada, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States
Maimonides Medical Center, Brooklyn, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
New York Proton Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Memorial Sloan Kettering Sleepy Hollow, Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Cleveland Clinic Akron General, Akron, Ohio, United States
Geauga Hospital, Chardon, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
Cleveland Clinic Cancer Center Mansfield, Mansfield, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Saint Francis Cancer Center, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, United States
Sandra L Maxwell Cancer Center, Cedar City, Utah, United States
Logan Regional Hospital, Logan, Utah, United States
Intermountain Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center, Provo, Utah, United States
Riverton Hospital, Riverton, Utah, United States
Saint George Regional Medical Center, Saint George, Utah, United States
Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Legacy Salmon Creek Hospital, Vancouver, Washington, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Marshfield Medical Center, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Chinese University of Hong Kong-Prince of Wales Hospital, Shatin, Hong Kong, China
Zhongshan Hospital Fudan University, Guangdong Province, Shanghai, China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Pamela Youde Nethersole Eastern Hospital, Chai Wan, , Hong Kong
Centro Comprensivo de Cancer de UPR, San Juan, , Puerto Rico
National Cancer Centre Singapore, Singapore, , Singapore
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Hospital-Lin Kou Medical Center, Taoyuan, , Taiwan
Name: Nancy Lee
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR