NCT02254278

Brief Summary

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_2

Geographic Reach
4 countries

222 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 12, 2020

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
Last Updated

October 9, 2025

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

September 29, 2014

Results QC Date

June 25, 2020

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)

    Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.

    From randomization to 2 years

Secondary Outcomes (13)

  • Percentage of Participants With Local-regional Failure

    From randomization to 2 years

  • Percentage of Participants With Distant Metastasis

    From randomization to 2 years

  • Percentage of Participants Alive

    from randomization to 2 years

  • Percentage of Participants With Grade 3+ Adverse Events

    End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT

  • Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)

    One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2

  • +8 more secondary outcomes

Study Arms (2)

IMRT 6 weeks + cisplatin

EXPERIMENTAL

IMRT 6 weeks with concurrent cisplatin

Drug: CisplatinRadiation: IMRT 6 weeks

IMRT 5 weeks

EXPERIMENTAL

IMRT 5 weeks

Radiation: IMRT 5 weeks

Interventions

40 mg/m2 IV (intravenously) weekly for 6 weeks

IMRT 6 weeks + cisplatin
IMRT 6 weeksRADIATION

Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy

Also known as: Intensity-Modulated Radiotherapy
IMRT 6 weeks + cisplatin
IMRT 5 weeksRADIATION

Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

Also known as: Intensity-Modulated Radiotherapy
IMRT 5 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Step 1: Registration:
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
  • Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review. Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry. FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review. If the p16 preparation is not adequate, additional specimens will be required to establish p16 status. Centers are encouraged to contact the pathology chairs for clarification.
  • Clinical stage T1-T2, N1-N2b or T3, N0-N2b (AJCC, 7th ed.) including no distant metastases based on the following diagnostic workup:
  • General history and physical examination within 56 days prior to registration;
  • Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration;
  • One of the following combinations of imaging is required within 56 days prior to registration:
  • A computed tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);
  • or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);
  • or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast);
  • or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
  • Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools.
  • Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history.
  • Number of pack-years = \[Frequency of smoking (number of cigarettes per day) Ă— duration of cigarette smoking (years)\] / 20
  • +21 more criteria

You may not qualify if:

  • Step 1: Registration:
  • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas;
  • Carcinoma of the neck of unknown primary site origin (even if p16 positive);
  • Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane;
  • Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
  • Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
  • Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.
  • Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers;
  • Prior invasive malignancy (except 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;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • Severe, active co-morbidity defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  • Transmural myocardial infarction within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (222)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Cancer Center

Sacramento, California, 95823, United States

Location

Naval Medical Center -San Diego

San Diego, California, 92134, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

Stanford Cancer Center South Bay

San Jose, California, 95124, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Saint Helena Hospital

St. Helena, California, 94574, United States

Location

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Cleveland Clinic-Weston

Weston, Florida, 33331, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Olathe Health Cancer Center

Olathe, Kansas, 66061, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States

Location

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

The University of Kansas Cancer Center-South

Kansas City, Missouri, 64131, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, 68803, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Alegent Health Lakeside Hospital

Omaha, Nebraska, 68130, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Saint Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

Wentworth-Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Virtua Memorial

Mount Holly, New Jersey, 08060, United States

Location

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Dickstein Cancer Treatment Center

White Plains, New York, 10601, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

ECU Health Oncology Kinston

Kinston, North Carolina, 28501, United States

Location

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, 28462, United States

Location

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, 28401, United States

Location

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

North Coast Cancer Care

Sandusky, Ohio, 44870, United States

Location

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States

Location

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, 15108, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, 15301, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Tennessee Cancer Specialists-Dowell Springs

Knoxville, Tennessee, 37909, United States

Location

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Tacoma/Valley Radiation Oncology Centers-Gig Harbor

Gig Harbor, Washington, 98332, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Tacoma/Valley Radiation Oncology Centers-Jackson Hall

Tacoma, Washington, 97405, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Tacoma/Valley Radiation Oncology Centers-Saint Joe's

Tacoma, Washington, 98405, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

Location

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, 53038, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Ascension All Saints Hospital

Racine, Wisconsin, 53405, United States

Location

HSHS Saint Nicholas Hospital

Sheboygan, Wisconsin, 53081, United States

Location

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Saint Lukes Hospital

Dublin, Co Dublin, 6, Ireland

Location

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

  • Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, Truong MT, Kong C, Jordan R, Subramaniam RM, Yao M, Chung CH, Geiger JL, Chan JW, O'Sullivan B, Blakaj DM, Mell LK, Thorstad WL, Jones CU, Banerjee RN, Lominska C, Le QT. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol. 2021 Mar 20;39(9):956-965. doi: 10.1200/JCO.20.03128. Epub 2021 Jan 28.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckTongue Neoplasms

Interventions

CisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title
Wendy Seiferheld
Organization
NRG Oncology

Study Officials

  • Sue Yom

    NRG Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

September 29, 2014

First Posted

October 1, 2014

Study Start

October 1, 2014

Primary Completion

June 10, 2019

Study Completion

September 4, 2025

Last Updated

October 9, 2025

Results First Posted

August 12, 2020

Record last verified: 2025-09

Locations