Head and Neck Cancer Clinical Trial
Official title:
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
Verified date | December 2016 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
known which radiation therapy regimen is more effective in treating patients with stage II
cancer of the vocal cord.
PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating
patients who have stage II cancer of the vocal cord.
Status | Completed |
Enrollment | 250 |
Est. completion date | December 2016 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven invasive squamous cell carcinoma of the true vocal cord - Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas - No verrucal carcinoma or adenocarcinoma - No extension to pre-epiglottic space or pyriform sinus - No fixed cord or cartilage invasion - No evidence of adenopathy, including any of the following: - Nodes larger than 1 cm by radiography - Nodes containing a low central density consistent with necrosis by radiography - Clinically palpable nodes larger than 1 cm and firm in consistency - No recurrent or persistent disease - No evidence or suspicion of distant metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other malignancy within the past 5 years except nonmelanomatous skin cancer - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the mid-neck or larynx Surgery: - No prior complete stripping or laser excision of all gross disease |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Center - Calgary | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | CHUS-Hopital Fleurimont | Fleurimont | Quebec |
Canada | Nova Scotia Cancer Centre | Halifax | Nova Scotia |
Canada | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario |
Canada | Kingston Regional Cancer Centre | Kingston | Ontario |
Canada | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario |
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | McGill University | Montreal | Quebec |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador |
Canada | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario |
Canada | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
United States | Akron City Hospital | Akron | Ohio |
United States | Akron General Medical Center | Akron | Ohio |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | Radiation Oncology Associates of Albuquerque | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Anne Arundel Oncology Center | Annapolis | Maryland |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Harbor Hospital Center | Baltimore | Maryland |
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Bloomington Hospital | Bloomington | Indiana |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Green Mountain Oncology Group | Burlington | Vermont |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Cancer Center at the University of Virginia | Charlottesville | Virginia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Barrett Cancer Center | Cincinnati | Ohio |
United States | Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Finger Lakes Radiation Oncology Center | Clifton Springs | New York |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Medical Center/John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Mount Diablo Medical Center | Concord | California |
United States | Northeast Medical Center | Concord | North Carolina |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Mercy Fitzgerald Hospital | Darby | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado |
United States | University of Colorado Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Pocono Cancer Center | East Stroudsburg | Pennsylvania |
United States | John F. Kennedy Medical Center | Edison | New Jersey |
United States | Trinitas Hospital - Jersey Street Campus | Elizabeth | New Jersey |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLaren Regional Cancer Center | Flint | Michigan |
United States | California Cancer Center | Fresno | California |
United States | Saint Agnes Cancer Center | Fresno | California |
United States | University of Florida Health Science Center | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Saint Mary's Hospital and Medical Center | Grand Junction | Colorado |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Sutter Health West Cancer Research Group | Greenbrae | California |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | RMH Regional Cancer Center | Harrisonburg | Virginia |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Comprehensive Cancer Institute of Huntsville | Huntsville | Alabama |
United States | Huntsville Hospital System | Huntsville | Alabama |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Clarian Health Partners Inc. | Indianapolis | Indiana |
United States | Community Regional Cancer Care | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | Florida Radiation Oncology Group | Jacksonville | Florida |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | Louisville Radiation Oncology | Louisville | Kentucky |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | Southern Wisconsin Radiotherapy Center | Madison | Wisconsin |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Merle M. Mahr Cancer Center | Madisonville | Kentucky |
United States | Elliot Regional Cancer Center | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Marquette General Hospital | Marquette | Michigan |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Holmes Regional Medical Center | Melbourne | Florida |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Veterans Affairs Medical Center - Miami | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MidMichigan Medical Center - Midland | Midland | Michigan |
United States | South Jersey Regional Cancer Center | Millville | New Jersey |
United States | Columbia Hospital | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | Alabama Oncology, LLC | Montgomery | Alabama |
United States | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly | New Jersey |
United States | Ball Memorial Hospital | Muncie | Indiana |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Hospital of St. Raphael | New Haven | Connecticut |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | St. Anthony Hospital | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Methodist Hospital Cancer Center - Omaha | Omaha | Nebraska |
United States | Nebraska Health System | Omaha | Nebraska |
United States | MD Anderson Cancer Center Orlando | Orlando | Florida |
United States | Bay Medical Center | Panama City | Florida |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Bayshore Medical Center | Pasadena | Texas |
United States | Huntington Cancer Center | Pasadena | California |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Veterans Affairs Medical Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Atlantic City Medical Center | Pomona | New Jersey |
United States | Robert and Beverly Lewis Family Cancer Care Center | Pomona | California |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Maine Medical Center | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
United States | Roger Williams Medical Center/BUSM | Providence | Rhode Island |
United States | All Saints Cancer Center | Racine | Wisconsin |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Bon Secours - St. Mary's Hospital | Richmond | Virginia |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | James P. Wilmot Cancer Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Regional Radiation Oncology Center at Rome | Rome | Georgia |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Radiation Oncology Center - Sacramento | Sacramento | California |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Mallinckrodt Institute of Radiology | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | Latter Day Saints Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | Radiation Medical Group, Incorporated | San Diego | California |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | O'Connor Hospital | San Jose | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | Sarasota Radiation and Medical Oncology Center | Sarasota | Florida |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | Tallahassee Memorial Healthcare | Tallahassee | Florida |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | St. Francis Medical Center | Trenton | New Jersey |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | CCOP - Oklahoma | Tulsa | Oklahoma |
United States | St. John Health System | Tulsa | Oklahoma |
United States | DCH Cancer Treatment Center | Tuscaloosa | Alabama |
United States | Associated Radiologists, P.A. | Warren | New Jersey |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Schiffler Cancer Center | Wheeling | West Virginia |
United States | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Riverhill Radiation Oncology | Yonkers | New York |
United States | York Cancer Center | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | No | |
Secondary | Acute Toxicity | From start of treatment to 90 days | Yes | |
Secondary | Late Toxicity | From 91 days after start of treatment to last follow-up. | Yes | |
Secondary | Overall Survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years | No | |
Secondary | Disease-free Survival | From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |