Individualized Treatment Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
4 other identifiers
interventional
685
8 countries
215
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
Longer than P75 for phase_2
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2014
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2031
May 7, 2026
April 1, 2026
12.8 years
May 7, 2014
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (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 log rank test. The confidence interval approach will be used for the final analysis of OS.
Up to 7 years
Progression-free survival (PFS) (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 log rank test. A one-sided log rank test will be used to compare the PFS at a significance level of 0.1379.
Up to 7 years
Secondary Outcomes (13)
Changes in pure tone audiometry (Phase II and III)
Baseline to up to 1 year
Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III)
Baseline to up to 24 months
Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III)
Baseline to up to 24 months
Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III)
Baseline to up to 24 months
Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III)
Up to 24 months
- +8 more secondary outcomes
Study Arms (4)
Arm I (chemoradiation, cisplatin, fluorouracil)
ACTIVE COMPARATORPatients 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 (chemoradiation, gemcitabine hydrochloride, 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.
Arm III (chemoradiation, cisplatin, fluorouracil)
ACTIVE COMPARATORPatients receive PF regimen as in Arm I of Phase II.
Arm IV (chemoradiation, observation)
EXPERIMENTALPatients undergo clinical observation.
Interventions
Given IV
Ancillary studies
Given IV
Given IV
Given IV
Undergo IMRT
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
You may not qualify if:
- Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
- ≥ Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
- Severe, active co-morbidity, defined as follows:
- Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy
- Unstable angina and/or uncontrolled congestive heart failure within the past 6 months
- Myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that Human Immunodeficiency Virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (215)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Fresno Cancer Center
Fresno, California, 93720, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, 95687, United States
SCL Health Cancer Centers of Colorado - Lutheran Medical Center
Golden, Colorado, 80401, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Yale University
New Haven, Connecticut, 06520, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Singh and Arora Hematology Oncology PC
Flint, Michigan, 48532, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
Mid-Michigan Physicians-Lansing
Lansing, Michigan, 48912, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
New York Proton Center
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China
Zhongshan Hospital Fudan University
Guangdong Province, Shanghai Municipality, 200032, China
Sun Yat-sen University Cancer Center
Guangzhou, 510060, China
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
National Cancer Centre Singapore
Singapore, 169610, Singapore
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Hospital-Lin Kou Medical Center
Taoyuan, 33333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Lee
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 9, 2014
Study Start
April 21, 2014
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2031
Last Updated
May 7, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.