Head and Neck Cancer Clinical Trial
Official title:
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Verified date | April 2023 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 743 |
Est. completion date | May 20, 2022 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx - Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) - No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 50 mL/min - Calcium normal Cardiovascular - No symptomatic coronary artery disease (angina) - No myocardial infarction within the past 6 months Other - No other invasive malignancy within the past 3 years except nonmelanoma skin cancer - No simultaneous primary tumors - Not pregnant or nursing - Negative pregnancy test - 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 head and neck except radioactive iodine therapy Surgery - No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease - No radical or modified neck dissection |
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Akron City Hospital at Summa Health System | Akron | Ohio |
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson | South Carolina |
United States | St. John's Cancer Center at St. John's Medical Center | Anderson | Indiana |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta | Georgia |
United States | Baton Rouge General Regional Cancer Center | Baton Rouge | Louisiana |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | St. Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Cancer Research Center at Boston Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green | Kentucky |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Cancer Institute of New Jersey at the Cooper University Hospital | Camden | New Jersey |
United States | Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio |
United States | Cancer Institute of Cape Girardeau | Cape Girardeau | Missouri |
United States | Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago | Illinois |
United States | Mount Sinai Hospital Medical Center | Chicago | Illinois |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Memorial Hospital Cancer Center | Colorado Springs | Colorado |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | John B. Amos Community Cancer Center | Columbus | Georgia |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa |
United States | John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden | North Carolina |
United States | Alexian Brothers Cancer Care Center | Elk Grove Village | Illinois |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Union Hospital Cancer Center at Union Hospital | Elkton | Maryland |
United States | Hudner Oncology Center at Saint Anne's Hospital | Fall River | Massachusetts |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida |
United States | 21st Century Oncology - Fort Myers | Fort Myers | Florida |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Shands Cancer Center at the University of Florida - Jacksonville | Gainesville | Florida |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina |
United States | Bon Secours St. Francis Health System | Greenville | South Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Greenville Hospital System Cancer Center | Greenville | South Carolina |
United States | Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois |
United States | Saint Rose Hospital | Hayward | California |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida |
United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
United States | Cape Cod Hospital | Hyannis | Massachusetts |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood | California |
United States | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida |
United States | University of Florida Shands Cancer Center | Jacksonville | Florida |
United States | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Rappahannock General Hospital | Kilmarnock | Virginia |
United States | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Valley Memorial Hospital | Livermore | California |
United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Holy Family Memorial Medical Center | Manitowoc | Wisconsin |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Middletown Regional Hospital | Middletown | Ohio |
United States | South Jersey Healthcare Regional Cancer Center | Millville | New Jersey |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | Providence Holy Cross Cancer Center | Mission Hills | California |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Fox Chase Virtua Health Cancer Program - Marlton | Mount Holly | New Jersey |
United States | Cottonwood Hospital Medical Center | Murray | Utah |
United States | Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee |
United States | Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | New Orleans Cancer Institute at Memorial Medical Center | New Orleans | Louisiana |
United States | Tulane Cancer Center | New Orleans | Louisiana |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Highland General Hospital | Oakland | California |
United States | Summit Medical Center | Oakland | California |
United States | Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska |
United States | Gulf Coast Cancer Treatment Center | Panama City | Florida |
United States | Cancer Center at Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York |
United States | Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth | Indiana |
United States | Pomona Valley Hospital Medical Center | Pomona | California |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | South Suburban Oncology Center | Quincy | Massachusetts |
United States | All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Annie Penn Cancer Center | Reidsville | North Carolina |
United States | Washoe Cancer Services at Washoe Medical Center - Reno | Reno | Nevada |
United States | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia |
United States | Veterans Affairs Medical Center - Richmond | Richmond | Virginia |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Radiological Associates of Sacramento Medical Group, Inc. | Sacramento | California |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Seton Cancer Institute - Saginaw | Saginaw | Michigan |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | Saint Louis University Cancer Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | J.C. Robinson, M.D. Regional Cancer Center | San Pablo | California |
United States | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Scottsdale Healthcare - Shea | Scottsdale | Arizona |
United States | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale | Arizona |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Community Memorial Health Center | South Hill | Virginia |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida |
United States | Community Medical Center | Toms River | New Jersey |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | LaFortune Cancer Center at St. John Health System | Tulsa | Oklahoma |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia |
United States | St. Francis Hospital | Wilmington | Delaware |
United States | Wilson Medical Center | Wilson | North Carolina |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | Cancer Treatment Center | Wooster | Ohio |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | North Star Lodge Cancer Center | Yakima | Washington |
United States | Washington Hematology - Oncology Specialists | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States,
Ang K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Onco
Ang K, Zhang Q, Wheeler RH, et al.: A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): impact of radiation and cisplatin intensity on outcome. [Abstract] J Clin Oncol 28 (Suppl 15): A-5507, 2010.
Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 J — View Citation
Gillison ML, Harris J, Westra W, et al.: Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. [Abstract] J Clin Oncol 27 (Suppl 15): A-6003, 2009.
Gillison ML, Zhang Q, Jordan R, Xiao W, Westra WH, Trotti A, Spencer S, Harris J, Chung CH, Ang KK. Tobacco smoking and increased risk of death and progression for patients with p16-positive and p16-negative oropharyngeal cancer. J Clin Oncol. 2012 Jun 10;30(17):2102-11. doi: 10.1200/JCO.2011.38.4099. Epub 2012 May 7. — View Citation
Wuthrick EJ, Zhang Q, Machtay M, et al.: The influence of institutional head and neck cancer (HNC) clinical trial accrual on overall survival (OS): An analysis of RTOG 0129. [Abstract] J Clin Oncol 30 (Suppl 15): A-5530, 2012.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (Percentage of Participants Alive) | Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here. | |
Secondary | Local-regional Failure (Percentage of Participants With Local-regional Failure) | Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here. | |
Secondary | Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure] | Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here. | |
Secondary | Disease-free Survival (Percentage of Participants Alive Without Disease) | Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here. | |
Secondary | Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression] | Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here. | |
Secondary | Percentage of Participants With Toxicity Grade 3 or Higher | Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data. | From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. | |
Secondary | Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year | The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC). | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. | |
Secondary | PSS-HN Public Eating Score - AUC at One Year | The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC). | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. | |
Secondary | PSS-HN Understandability of Speech Score - AUC at One Year | The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC). | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. | |
Secondary | Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year | The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC). | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. | |
Secondary | Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes | From randomization to date of death or last follow-up | ||
Secondary | Correlation of COX-2 With Outcomes | From randomization to date of death or last follow-up |
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