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Spots Global Cancer Trial Database for Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Nancy Lee

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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