Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

Who is this study for? Patients with nasopharyngeal carcinoma
Status: Recruiting
Location: See all (209) locations...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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 (see Section 10.2 for details of specimen submission).

• For patients who have detectable plasma EBV DNA tested at one of the credentialed central labs (listed on the EBV DNA Testing Specimen Transmittal form) 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, and the site must follow the instructions in Section 5.4.

• Stage II-IVB disease (AJCC, 7th 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 ENT, which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration;

• Evaluation of tumor extent required within 28 days prior to registration:

• MRI of the nasopharynx and neck; or 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.

• Please refer to section 6.3.2 for MRI requirement for target delineation.

• 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

• 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) and 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

Locations
United States
Alabama
The Kirklin Clinic at Acton Road
Suspended
Birmingham
University of Alabama at Birmingham Cancer Center
Recruiting
Birmingham
Arizona
Banner University Medical Center - Tucson
Active, not recruiting
Tucson
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Recruiting
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Recruiting
Berkeley
Mills-Peninsula Medical Center
Suspended
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Recruiting
Cameron Park
City of Hope Comprehensive Cancer Center
Recruiting
Duarte
Kaiser Permanente Dublin
Recruiting
Dublin
Fresno Cancer Center
Recruiting
Fresno
UC San Diego Moores Cancer Center
Active, not recruiting
La Jolla
Memorial Medical Center
Recruiting
Modesto
Kaiser Permanente Oakland-Broadway
Recruiting
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
Suspended
Orange
Palo Alto Medical Foundation Health Care
Recruiting
Palo Alto
Stanford Cancer Institute Palo Alto
Recruiting
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Recruiting
Rancho Cordova
Rohnert Park Cancer Center
Recruiting
Rohnert Park
Sutter Cancer Centers Radiation Oncology Services-Roseville
Recruiting
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Recruiting
Roseville
South Sacramento Cancer Center
Recruiting
Sacramento
Sutter Medical Center Sacramento
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Active, not recruiting
Sacramento
California Pacific Medical Center-Pacific Campus
Recruiting
San Francisco
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
UCSF Medical Center-Mount Zion
Recruiting
San Francisco
Kaiser Permanente Medical Center - Santa Clara
Recruiting
Santa Clara
City of Hope South Pasadena
Recruiting
South Pasadena
Kaiser Permanente Cancer Treatment Center
Recruiting
South San Francisco
Palo Alto Medical Foundation-Sunnyvale
Recruiting
Sunnyvale
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Recruiting
Vacaville
Colorado
SCL Health Cancer Centers of Colorado - Lutheran Medical Center
Suspended
Golden
North Colorado Medical Center
Suspended
Greeley
McKee Medical Center
Suspended
Loveland
Parker Adventist Hospital
Suspended
Parker
SCL Health Lutheran Medical Center
Suspended
Wheat Ridge
Connecticut
Yale University
Recruiting
New Haven
Delaware
Christiana Care Health System-Christiana Hospital
Active, not recruiting
Newark
Helen F Graham Cancer Center
Active, not recruiting
Newark
Florida
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville
Moffitt Cancer Center
Suspended
Tampa
Georgia
Emory Proton Therapy Center
Recruiting
Atlanta
Emory Saint Joseph's Hospital
Recruiting
Atlanta
Emory University Hospital Midtown
Recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Recruiting
Atlanta
Hawaii
The Cancer Center of Hawaii-Pali Momi
Recruiting
'aiea
Queen's Medical Center
Recruiting
Honolulu
The Cancer Center of Hawaii-Liliha
Recruiting
Honolulu
Iowa
Iowa Methodist Medical Center
Active, not recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Alphonsus Cancer Care Center-Boise
Active, not recruiting
Boise
Illinois
Rush - Copley Medical Center
Recruiting
Aurora
John H Stroger Jr Hospital of Cook County
Recruiting
Chicago
Northwestern University
Recruiting
Chicago
Cancer Care Specialists of Illinois - Decatur
Recruiting
Decatur
Decatur Memorial Hospital
Recruiting
Decatur
Crossroads Cancer Center
Recruiting
Effingham
Memorial Medical Center
Recruiting
Springfield
Carle Cancer Center
Recruiting
Urbana
Indiana
Memorial Hospital of South Bend
Recruiting
South Bend
Kansas
Ascension Via Christi Hospitals Wichita
Recruiting
Wichita
Wesley Medical Center
Recruiting
Wichita
Massachusetts
Boston Medical Center
Recruiting
Boston
Massachusetts General Hospital Cancer Center
Recruiting
Boston
Tufts Medical Center
Recruiting
Boston
Maryland
Greater Baltimore Medical Center
Recruiting
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Active, not recruiting
Baltimore
Michigan
Saint Joseph Mercy Hospital
Recruiting
Ann Arbor
University of Michigan Comprehensive Cancer Center
Recruiting
Ann Arbor
McLaren Cancer Institute-Bay City
Active, not recruiting
Bay City
Henry Ford Cancer Institute-Downriver
Recruiting
Brownstown
Saint Joseph Mercy Canton
Recruiting
Canton
McLaren Cancer Institute-Clarkston
Active, not recruiting
Clarkston
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township
Henry Ford Hospital
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Active, not recruiting
Detroit
Weisberg Cancer Treatment Center
Active, not recruiting
Farmington Hills
McLaren Cancer Institute-Flint
Active, not recruiting
Flint
Singh and Arora Hematology Oncology PC
Active, not recruiting
Flint
Karmanos Cancer Institute at McLaren Greater Lansing
Active, not recruiting
Lansing
Mid-Michigan Physicians-Lansing
Active, not recruiting
Lansing
Sparrow Hospital
Recruiting
Lansing
McLaren Cancer Institute-Lapeer Region
Active, not recruiting
Lapeer
Trinity Health Saint Mary Mercy Livonia Hospital
Recruiting
Livonia
McLaren Cancer Institute-Macomb
Active, not recruiting
Mount Clemens
McLaren Cancer Institute-Central Michigan
Active, not recruiting
Mount Pleasant
McLaren Cancer Institute-Northern Michigan
Active, not recruiting
Petoskey
Saint Joseph Mercy Oakland
Recruiting
Pontiac
McLaren-Port Huron
Active, not recruiting
Port Huron
Ascension Saint Mary's Hospital
Recruiting
Saginaw
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield
Minnesota
Fairview Ridges Hospital
Suspended
Burnsville
Minnesota Oncology - Burnsville
Recruiting
Burnsville
Unity Hospital
Recruiting
Fridley
Minnesota Oncology Hematology PA-Maplewood
Recruiting
Maplewood
Hennepin County Medical Center
Recruiting
Minneapolis
North Memorial Medical Health Center
Recruiting
Robbinsdale
Mayo Clinic in Rochester
Recruiting
Rochester
Regions Hospital
Recruiting
Saint Paul
Rice Memorial Hospital
Recruiting
Willmar
Missouri
Saint Francis Medical Center
Recruiting
Cape Girardeau
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
Delbert Day Cancer Institute at PCRMC
Recruiting
Rolla
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
CoxHealth South Hospital
Recruiting
Springfield
Mercy Hospital Springfield
Recruiting
Springfield
Montana
Saint James Community Hospital and Cancer Treatment Center
Suspended
Butte
Nebraska
Nebraska Methodist Hospital
Recruiting
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
Recruiting
Basking Ridge
Memorial Sloan Kettering Monmouth
Recruiting
Middletown
Memorial Sloan Kettering Bergen
Recruiting
Montvale
Rutgers Cancer Institute of New Jersey
Recruiting
New Brunswick
Rutgers New Jersey Medical School
Suspended
Newark
Nevada
Radiation Oncology Centers of Nevada Central
Recruiting
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
Saint Mary's Regional Medical Center
Recruiting
Reno
New York
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Montefiore Medical Center-Einstein Campus
Recruiting
Bronx
Maimonides Medical Center
Active, not recruiting
Brooklyn
New York-Presbyterian/Brooklyn Methodist Hospital
Recruiting
Brooklyn
Memorial Sloan Kettering Commack
Recruiting
Commack
Memorial Sloan Kettering Westchester
Recruiting
Harrison
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Suspended
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
New York Proton Center
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Active, not recruiting
New York
University of Rochester
Recruiting
Rochester
Memorial Sloan Kettering Sleepy Hollow
Active, not recruiting
Sleepy Hollow
Memorial Sloan Kettering Nassau
Recruiting
Uniondale
Ohio
Cleveland Clinic Akron General
Active, not recruiting
Akron
Geauga Hospital
Recruiting
Chardon
University of Cincinnati Cancer Center-UC Medical Center
Recruiting
Cincinnati
Case Western Reserve University
Recruiting
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Recruiting
Cleveland
Cleveland Clinic Foundation
Recruiting
Cleveland
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Mercy Cancer Center-Elyria
Suspended
Elyria
Cleveland Clinic Cancer Center Mansfield
Recruiting
Mansfield
North Coast Cancer Care
Recruiting
Sandusky
Cleveland Clinic Cancer Center Strongsville
Recruiting
Strongsville
ProMedica Flower Hospital
Recruiting
Sylvania
University of Cincinnati Cancer Center-West Chester
Suspended
West Chester
UHHS-Westlake Medical Center
Recruiting
Westlake
Cleveland Clinic Wooster Family Health and Surgery Center
Recruiting
Wooster
Oklahoma
Mercy Hospital Oklahoma City
Recruiting
Oklahoma City
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
Active, not recruiting
Gresham
Legacy Good Samaritan Hospital and Medical Center
Active, not recruiting
Portland
Pennsylvania
Christiana Care Health System-Concord Health Center
Active, not recruiting
Chadds Ford
Geisinger Medical Center
Recruiting
Danville
Geisinger Medical Oncology-Lewisburg
Recruiting
Lewisburg
Lewistown Hospital
Recruiting
Lewistown
Geisinger Cancer Services-Pottsville
Recruiting
Pottsville
Reading Hospital
Recruiting
West Reading
Geisinger Wyoming Valley/Henry Cancer Center
Recruiting
Wilkes-barre
South Carolina
Prisma Health Cancer Institute - Spartanburg
Active, not recruiting
Boiling Springs
Prisma Health Cancer Institute - Eastside
Active, not recruiting
Greenville
Prisma Health Cancer Institute - Faris
Active, not recruiting
Greenville
Saint Francis Cancer Center
Active, not recruiting
Greenville
Gibbs Cancer Center-Pelham
Recruiting
Greer
Prisma Health Cancer Institute - Greer
Active, not recruiting
Greer
Prisma Health Cancer Institute - Seneca
Active, not recruiting
Seneca
Spartanburg Medical Center
Recruiting
Spartanburg
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
M D Anderson Cancer Center
Recruiting
Houston
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
Recruiting
American Fork
Sandra L Maxwell Cancer Center
Recruiting
Cedar City
Logan Regional Hospital
Recruiting
Logan
Intermountain Medical Center
Recruiting
Murray
McKay-Dee Hospital Center
Recruiting
Ogden
Utah Valley Regional Medical Center
Recruiting
Provo
Riverton Hospital
Recruiting
Riverton
Saint George Regional Medical Center
Recruiting
Saint George
Utah Cancer Specialists-Salt Lake City
Recruiting
Salt Lake City
Virginia
Inova Schar Cancer Institute
Recruiting
Fairfax
Inova Fairfax Hospital
Recruiting
Falls Church
Naval Medical Center - Portsmouth
Recruiting
Portsmouth
Washington
Legacy Salmon Creek Hospital
Active, not recruiting
Vancouver
Wisconsin
HSHS Sacred Heart Hospital
Suspended
Eau Claire
Gundersen Lutheran Medical Center
Recruiting
La Crosse
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center
Suspended
Marshfield
Medical College of Wisconsin
Active, not recruiting
Milwaukee
Marshfield Clinic-Minocqua Center
Recruiting
Minocqua
Marshfield Medical Center-Rice Lake
Recruiting
Rice Lake
Ascension Saint Michael's Hospital
Suspended
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Recruiting
Stevens Point
Diagnostic and Treatment Center
Recruiting
Weston
Marshfield Medical Center - Weston
Recruiting
Weston
Other Locations
Australia
Peter MacCallum Cancer Centre
Active, not recruiting
Melbourne
Canada
Tom Baker Cancer Centre
Recruiting
Calgary
Cross Cancer Institute
Recruiting
Edmonton
London Regional Cancer Program
Recruiting
London
Jewish General Hospital
Recruiting
Montreal
McGill University Department of Oncology
Recruiting
Montreal
The Research Institute of the McGill University Health Centre (MUHC)
Recruiting
Montreal
University Health Network-Princess Margaret Hospital
Recruiting
Toronto
China
Zhongshan Hospital Fudan University
Suspended
Guangdong Province
Sun Yat-sen University Cancer Center
Recruiting
Guangzhou
Chinese University of Hong Kong-Prince of Wales Hospital
Recruiting
Shatin
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital
Recruiting
Chai Wan
Puerto Rico
Centro Comprensivo de Cancer de UPR
Suspended
San Juan
Singapore
National Cancer Centre Singapore
Recruiting
Singapore
Taiwan
National Taiwan University Hospital
Suspended
Taipei
Chang Gung Hospital-Lin Kou Medical Center
Suspended
Taoyuan
Time Frame
Start Date: April 2014
Estimated Completion Date: July 2029
Participants
Target number of participants: 758
Treatments
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.
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.
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.
Authors
Anthony T. Chan, Tyler J. Kemmis, Laila A. Gharzai, John F. Deeken, Benjamin J. George, Sharon A. Spencer, Robert J. Behrens, Minh T. Truong, Charles Shideman, Nancy Lee, Jonathan J. Beitler, Jennifer A. Dorth, Bryan A. Faller, Min Yao, Nayana L. Vora, Patricia C. Griffin, Paul W. Sperduto, Samuel Ejadi, Chaitali S. Nangia, Vilija N. Avizonis, Yuhchyau Chen, Rupali Nabar, Andrew Y. Kee, Jay W. Carlson, Eric P. Kielhorn, Kenneth S. Hu, Kalika P. Sarma, David J. Adelstein, David J. Sher, Anand Mahadevan, David A. Hornback, Sue S. Yom, Kevin P. Redmond, Robert L. Foote, Carryn M. Anderson, Ana P. Kiess, Jeffrey K. Giguere, Missak Haigentz, Jessica L. Geiger, Kenneth N. Sumida, Thomas E. Lad, Christopher U. Jones, Gregory A. Masters, Keren Sturtz, Matthen Mathew, Abhijit B. Saste, Ammar Sukari, Robert E. Martell, Shyam S. Rao, Malini Patel, Eleanor M. Walker, Joshua Lukenbill, Madhur K. Garg, Mitchel L. Fromm, Ranee Mehra, Robert D. Siegel, Samir Narayan, Nicholas DiBella, Fiori Alite, Hani L. Ashamalla, Terrence P. Cescon, Luis Baez-Diaz, Annie W. Chan, Jay S. Cooper, Collin D. Driscoll, Bharat B. Mittal, Shaker R. Dakhil, Francis P. Worden, Douglas R. Adkins, Jordan Kharofa, Samantha A. Seaward, Henry S. Park, Gary B. Gunn, Zain A. Husain, James L. Wade, Terence S. Herman, Paul M. Harari, Quynh-Thu X. Le, Yu Cao, Michael Husak, Andrew S. Camarata, Mridula Sara Kuruvilla, Anterpreet S. Neki, Wai T. Ng, J. S. Thompson, Henry C. Sze, Krishnamurthi Sundaram, Marc Webster, Yoke L. Soong, George Shenouda, Chaosu Hu, Neil S. Chua, Dukagjin M. Blakaj, David L. Schwartz, Amarinthia (Amy) Curtis, Tien-Shew W. Huang, Yun-Fei Xia, John A. Ellerton, Biren Saraiya, Suzanne Richter, Mei Tang, John (Joon-Hyung) Kim, Ruey-Long Hong, William Stokes, Khalil Sultanem
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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