A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

Who is this study for? Adult patients with oropharyngeal squamous cell carcinoma
Status: Active, not recruiting
Location: See all (222) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

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

• 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) × duration of cigarette smoking (years)] / 20

• Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone.

• Zubrod Performance Status of 0-1 within 56 days prior to registration;

• Age ≥ 18;

• The trial is open to both genders;

• Adequate hematologic function within 14 days prior to registration, defined as follows:

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;

• Platelets ≥ 100,000 cells/mm3;

• Hemoglobin (Hgb) ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.

• Adequate renal function within 14 days prior to registration, defined as follows:

• • Serum creatinine (Cr) < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:

• CC male = [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]

• CC female = 0.85 x (CC male)

• Adequate hepatic function within 14 days prior to registration defined as follows:

• Bilirubin < 2 mg/dl;

• Aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x the upper limit of normal.

• Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;

• Patients who are HIV positive but have no prior Acquired Immune Deficiency Syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).

• The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review.

• Patients who speak English (or read one of the languages for which a translation is available (see Section 10.2) must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI). If the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics. For all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied.

• Step 2: Randomization:

• p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review; (see Section 10.1 for details).

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arizona
Banner MD Anderson Cancer Center
Gilbert
Banner University Medical Center - Tucson
Tucson
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mills-Peninsula Medical Center
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
City of Hope Comprehensive Cancer Center
Duarte
Marin General Hospital
Greenbrae
UC San Diego Moores Cancer Center
La Jolla
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Memorial Medical Center
Modesto
Kaiser Permanente Oakland-Broadway
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Stanford Cancer Institute Palo Alto
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova
Rohnert Park Cancer Center
Rohnert Park
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
South Sacramento Cancer Center
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Saint Helena Hospital
Saint Helena
Naval Medical Center -San Diego
San Diego
UCSF Medical Center-Mount Zion
San Francisco
Stanford Cancer Center South Bay
San Jose
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
City of Hope South Pasadena
South Pasadena
Kaiser Permanente Cancer Treatment Center
South San Francisco
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
John Muir Medical Center-Walnut Creek
Walnut Creek
Colorado
University of Colorado Hospital
Aurora
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
Swedish Medical Center
Englewood
Poudre Valley Hospital
Fort Collins
North Colorado Medical Center
Greeley
Parker Adventist Hospital
Parker
Connecticut
Yale University
New Haven
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Beebe Health Campus
Rehoboth Beach
Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Miami Cancer Institute
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Memorial Hospital West
Pembroke Pines
Moffitt Cancer Center
Tampa
Cleveland Clinic-Weston
Weston
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Grady Health System
Atlanta
Piedmont Hospital
Atlanta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Hawaii
Queen's Medical Center
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Decatur Memorial Hospital
Decatur
NorthShore University HealthSystem-Evanston Hospital
Evanston
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Loyola University Medical Center
Maywood
Indiana
Parkview Hospital Randallia
Fort Wayne
Radiation Oncology Associates PC
Fort Wayne
Memorial Hospital of South Bend
South Bend
Kansas
University of Kansas Cancer Center
Kansas City
Lawrence Memorial Hospital
Lawrence
Olathe Medical Center
Olathe
University of Kansas Cancer Center-Overland Park
Overland Park
Ascension Via Christi Hospitals Wichita
Wichita
Kentucky
Jewish Hospital Medical Center Northeast
Louisville
The James Graham Brown Cancer Center at University of Louisville
Louisville
Massachusetts
Boston Medical Center
Boston
Lahey Hospital and Medical Center
Burlington
Maryland
Greater Baltimore Medical Center
Baltimore
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Hospital
Detroit
Mercy Health Saint Mary's
Grand Rapids
Saint Mary Mercy Hospital
Livonia
Mercy Health Mercy Campus
Muskegon
Lakeland Medical Center Saint Joseph
Saint Joseph
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Mercy Hospital
Coon Rapids
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Missouri
Siteman Cancer Center at West County Hospital
Creve Coeur
North Kansas City Hospital
Kansas City
The University of Kansas Cancer Center-North
Kansas City
The University of Kansas Cancer Center-South
Kansas City
The University of Kansas Cancer Center-Lee's Summit
Lee's Summit
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Hospital Saint Louis
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Montana
Billings Clinic Cancer Center
Billings
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Community Medical Hospital
Missoula
North Carolina
Mission Hospital Inc-Memorial Campus
Asheville
Vidant Oncology-Kinston
Kinston
NHRMC Radiation Oncology - Supply
Supply
NHRMC Radiation Oncology - 16th Street
Wilmington
Nebraska
CHI Health Saint Francis
Grand Island
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Wentworth-Douglass Hospital
Dover
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Saint Barnabas Medical Center
Livingston
Virtua Memorial
Mount Holly
Virtua Voorhees
Voorhees
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Radiation Oncology Centers of Nevada Central
Las Vegas
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
Memorial Sloan Kettering Nassau
Uniondale
Dickstein Cancer Treatment Center
White Plains
Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood
Geauga Hospital
Chardon
University of Cincinnati/Barrett Cancer Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Mercy Cancer Center-Elyria
Elyria
Cleveland Clinic Cancer Center Independence
Independence
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights
University Hospitals Parma Medical Center
Parma
North Coast Cancer Care
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky
Cleveland Clinic Cancer Center Strongsville
Strongsville
ProMedica Flower Hospital
Sylvania
University Pointe
West Chester
UHHS-Westlake Medical Center
Westlake
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster
Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
Gresham
Pennsylvania
Abington Memorial Hospital
Abington
UPMC-Heritage Valley Health System Beaver
Beaver
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
Penn State Milton S Hershey Medical Center
Hershey
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown
UPMC Cancer Center at UPMC McKeesport
Mckeesport
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon
Fox Chase Cancer Center
Philadelphia
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
UPMC Cancer Center at UPMC Northwest
Seneca
UPMC Uniontown Hospital Radiation Oncology
Uniontown
UPMC Washington Hospital Radiation Oncology
Washington
Reading Hospital
West Reading
South Carolina
Medical University of South Carolina
Charleston
Greenville Health System Cancer Institute-Eastside
Greenville
Greenville Health System Cancer Institute-Faris
Greenville
Greenville Health System Cancer Institute-Greer
Greer
Greenville Health System Cancer Institute-Seneca
Seneca
Greenville Health System Cancer Institute-Spartanburg
Spartanburg
Spartanburg Medical Center
Spartanburg
Tennessee
Tennessee Cancer Specialists-Dowell Springs
Knoxville
Texas
University of Texas Medical Branch
Galveston
M D Anderson Cancer Center
Houston
MD Anderson in Katy
Houston
UTMB Cancer Center at Victory Lakes
League City
MD Anderson League City
Nassau Bay
MD Anderson in The Woodlands
The Woodlands
Utah
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Huntsman Cancer Institute/University of Utah
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
University of Virginia Cancer Center
Charlottesville
Virginia Commonwealth University/Massey Cancer Center
Richmond
Vermont
Norris Cotton Cancer Center-North
Saint Johnsbury
Washington
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor
Virginia Mason Medical Center
Seattle
MultiCare Tacoma General Hospital
Tacoma
Tacoma/Valley Radiation Oncology Centers-Jackson Hall
Tacoma
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma
Legacy Salmon Creek Hospital
Vancouver
Wisconsin
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
UW Cancer Center Johnson Creek
Johnson Creek
Gundersen Lutheran Medical Center
La Crosse
University of Wisconsin Hospital and Clinics
Madison
Community Memorial Hospital
Menomonee Falls
Medical College of Wisconsin
Milwaukee
Ascension All Saints Hospital
Racine
HSHS Saint Nicholas Hospital
Sheboygan
The Alyce and Elmore Kraemer Cancer Care Center
West Bend
Aspirus UW Cancer Center
Wisconsin Rapids
Other Locations
Canada
Tom Baker Cancer Centre
Calgary
Cross Cancer Institute
Edmonton
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Kingston Health Sciences Centre
Kingston
CHUM - Hopital Notre-Dame
Montreal
Jewish General Hospital
Montreal
McGill University Department of Oncology
Montreal
Allan Blair Cancer Centre
Regina
Saskatoon Cancer Centre
Saskatoon
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
University Health Network-Princess Margaret Hospital
Toronto
BCCA-Vancouver Island Cancer Centre
Victoria
Windsor Regional Cancer Centre
Windsor
Ireland
Saint Lukes Hospital
Dublin
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Riyadh
Time Frame
Start Date: October 2014
Estimated Completion Date: May 31, 2024
Participants
Target number of participants: 316
Treatments
Experimental: IMRT 6 weeks + cisplatin
IMRT 6 weeks with concurrent cisplatin
Experimental: IMRT 5 weeks
IMRT 5 weeks
Authors
Miguel A. Conde, Parima Daroui, Lloyd T. Miyawaki, Adam W. Nowlan, Sharon A. Spencer, Minh T. Truong, Matthew L. Ryan, Harvey B. Wilds, Jonathan J. Beitler, Stephen J. Banks, Min Yao, Ming Pan, Nayana L. Vora, Jared R. Robbins, Paul W. Sperduto, Vilija N. Avizonis, Andrew Y. Kee, Jay W. Carlson, Wade L. Thorstad, Marcio A. Fagundes, Mehmet S. Copur, Adam S. Garden, Neal E. Dunlap, David J. Adelstein, Loren K. Mell, David A. Hornback, Sue Yom, Mehee Choi, Arul Mahadevan, Anand K. Sharma, Wayne H. Pinover, Kevin P. Redmond, Kenneth N. Sumida, Thomas E. Lad, Christopher U. Jones, Shiyu Song, Jeffrey H. Muler, Gregory A. Masters, Keren Sturtz, Parvesh Kumar, Brian K. Chang, Shyam S. Rao, Eleanor M. Walker, Weining (. Zhen, Nagy Elsayyad, Joshua T. Mckenzie, Samir Narayan, David L. Grisell, Maura L. Gillison, Terrence P. Cescon, Peter R. Watson, Collin D. Driscoll, Lemuel S. Ariaratnam, Shaker R. Dakhil, Ying J. Hitchcock, Samantha A. Seaward, Alan C. Hartford, Geoffrey A. Neuner, Sana D. Karam, Zain A. Husain, Michael A. Papagikos, Michael R. Girvigian, Robyn N. Banerjee, Benjamin T. Marchello, Terence S. Herman, Gregory Gan, James H. Taylor, Paul M. Harari, Quynh-Thu X. Le, Sun K. Yi, Marjaneh Moini, Louise Lambert, Srinath Sundararaman, Derek Suderman, Hosam (Sam) A. Kader, Justin Lee, Ali A. El-Gayed, Nasser M. Al-Rajhi, Do-Hoon Kim, George Shenouda, Jimmy J. Caudell, Amarinthia (Amy) Curtis, Tien-Shew W. Huang, David A. Clump, Kathleen J. Yost, John A. Ellerton, John A. Keech, John N. Waldron, Khalil Sultanem
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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