Head and Neck Cancer Clinical Trial
Official title:
Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck
Verified date | November 2015 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor
cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in
treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 2010 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx - Gross total resection completed or planned - No less than gross total resection - No disease requiring staging surgery - Prior gross total resection completed with one or more of the following risk factors: - Histologically proven multiple lymph node metastases - At least 1 lymph node with extracapsular extension of tumor - Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR - Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following: - Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm - Single clinically/radiologically evident lymph node of at least 3 cm - Histologically proven lymph node metastases - No T3, N0 glottic cancer - No nasopharyngeal or paranasal sinus carcinoma - No distant metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - White blood cell (WBC) at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 ULN Cardiovascular: - No unstable angina - No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty - No uncontrolled arrhythmia - No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place Pulmonary: - No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No pre-existing grade 2 or greater peripheral neurotoxicity - No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer - No significant wound infection - No fistula - No major wound dehiscence - Nutritional status adequate PRIOR CONCURRENT THERAPY: Biologic therapy: - Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to head and neck Surgery: - See Disease Characteristics |
Intervention Model: Single Group 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 - Ann Arbor Regional | 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 | 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 | 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 | Regional Cancer Center | 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 | Health First 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 | 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 Medical 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 | 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 | Huntington Cancer Center | Pasadena | California |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
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 | University of Pennsylvania Cancer Center | 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, Inc. | 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 | Waukesha | Wisconsin |
United States | Schiffler Cancer Center | Wheeling | West Virginia |
United States | Wilkes Barre General Hospital | Wilkes-Barre | Pennsylvania |
United States | CCOP - Christiana Care Health Services | Wilmington | Delaware |
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,
Rosenthal DI, Harris J, Forastiere AA, Weber RS, Ridge JA, Myers JN, Garden AS, Kuettel MR, Sidhu K, Schultz CJ, Trotti A, Ang KK. Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with rese — View Citation
Rosenthal DJ, Harris J, Forastiere AA, et al.: Early postoperative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy (RT) (phase II trial RTOG H-0024) is well tolerated for patients with resected, high-risk squamous carcino
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient tolerance of the treatment regimen | From registration to end of treatment | No | |
Secondary | Frequency of grade 5 and acute non-hematologic grade 4 toxicity | From start of induction chemotherapy to 90 days after start of radiation therapy | Yes | |
Secondary | Frequency of other acute and late toxicity | From start of induction chemotherapy to last follow-up | Yes | |
Secondary | Local-regional control | From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | No | |
Secondary | Disease-free survival | From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | No | |
Secondary | Overall survival | From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | No |
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