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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000257233 | |||
| RTOG-H-0129 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor.
Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years.
Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fractionation RT + cisplatin | Other | Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients. |
|
| Accelerated fractionation RT + cisplatin | Experimental | Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | 100 mg/m^2 intravenously on days 1, 22 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
No metastases below the clavicle or more distant by clinical exam or radiology
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease
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| Name | Affiliation | Role |
|---|---|---|
| Phuc Felix Nguyen-Tan, MD | CHUM Hospital Notre Dame | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22565003 | Background | 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. | |
| Result | 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. | ||
| 20530316 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Fractionation RT + Cisplatin | Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients. |
| FG001 | Accelerated Fractionation RT + Cisplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard fractionation RT | Radiation | Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy. |
|
| Accelerated fractionation radiation therapy | Radiation | Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks. |
|
| Conventional surgery for select patients | Procedure | Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer. A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made. |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes | From randomization to date of death or last follow-up |
| Correlation of COX-2 With Outcomes | From randomization to date of death or last follow-up |
| Mobile Infirmary Medical Center |
| Mobile |
| Alabama |
| 36607 |
| United States |
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | United States |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona | 85259 | United States |
| Scottsdale Healthcare - Shea | Scottsdale | Arizona | 85260 | United States |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale | Arizona | 85260 | United States |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| Saint Rose Hospital | Hayward | California | 94545 | United States |
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital | Inglewood | California | 90301 | United States |
| Valley Memorial Hospital | Livermore | California | 94550 | United States |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States |
| Providence Holy Cross Cancer Center | Mission Hills | California | 91346-9600 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Summit Medical Center | Oakland | California | 94609 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Radiological Associates of Sacramento Medical Group, Inc. | Sacramento | California | 95815 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Naval Medical Center - San Diego | San Diego | California | 92134 | United States |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo | California | 94806 | United States |
| Memorial Hospital Cancer Center | Colorado Springs | Colorado | 80909 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | 80217-3364 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19718 | United States |
| St. Francis Hospital | Wilmington | Delaware | 19805 | United States |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| 21st Century Oncology - Fort Myers | Fort Myers | Florida | 33901 | United States |
| Shands Cancer Center at the University of Florida - Jacksonville | Gainesville | Florida | 32610 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Florida Shands Cancer Center | Jacksonville | Florida | 32209 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Gulf Coast Cancer Treatment Center | Panama City | Florida | 32405 | United States |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612 | United States |
| Georgia Cancer Center for Excellence at Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| John B. Amos Community Cancer Center | Columbus | Georgia | 31904 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403 | United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| Mount Sinai Hospital Medical Center | Chicago | Illinois | 60608 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | United States |
| Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | United States |
| Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | United States |
| Alexian Brothers Cancer Care Center | Elk Grove Village | Illinois | 60007 | United States |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| St. John's Cancer Center at St. John's Medical Center | Anderson | Indiana | 46016 | United States |
| St. Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth | Indiana | 46544 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Cancer Treatment Center at the Medical Center - Bowling Green | Bowling Green | Kentucky | 42101 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | United States |
| Baton Rouge General Regional Cancer Center | Baton Rouge | Louisiana | 70806 | United States |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans | Louisiana | 70112 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| New Orleans Cancer Institute at Memorial Medical Center | New Orleans | Louisiana | 70115 | United States |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Union Hospital Cancer Center at Union Hospital | Elkton | Maryland | 21921 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Cancer Research Center at Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Hudner Oncology Center at Saint Anne's Hospital | Fall River | Massachusetts | 02721 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| South Suburban Oncology Center | Quincy | Massachusetts | 02169 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48100 | United States |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Hurley Medical Center | Flint | Michigan | 48502 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48532 | United States |
| Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint | Michigan | 48532 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49001 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48903 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Cancer Institute of Cape Girardeau | Cape Girardeau | Missouri | 63703 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno | Nevada | 89502 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | United States |
| South Jersey Healthcare Regional Cancer Center | Millville | New Jersey | 08332 | United States |
| Fox Chase Virtua Health Cancer Program - Marlton | Mount Holly | New Jersey | 08060 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York | 12901 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203 | United States |
| John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden | North Carolina | 27288 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27401 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Trinity Cancer Care Center | Minot | North Dakota | 58701 | United States |
| Akron City Hospital at Summa Health System | Akron | Ohio | 44304 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio | 44710-1799 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| LaFortune Cancer Center at St. John Health System | Tulsa | Oklahoma | 74104 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Cancer Center at Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania | 18501 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson | South Carolina | 29621 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| Greenville Hospital System Cancer Center | Greenville | South Carolina | 29605 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29304 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
| Harrington Cancer Center | Amarillo | Texas | 79106 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84603 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Rappahannock General Hospital | Kilmarnock | Virginia | 22482 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
| Community Memorial Health Center | South Hill | Virginia | 23970-0090 | United States |
| North Star Lodge Cancer Center | Yakima | Washington | 98902 | United States |
| Washington Hematology - Oncology Specialists | Yakima | Washington | 98902 | United States |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center | Green Bay | Wisconsin | 54303 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| Holy Family Memorial Medical Center | Manitowoc | Wisconsin | 54221 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus | Milwaukee | Wisconsin | 53211 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066-3896 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | United States |
| Result |
| 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 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7. |
| Result | 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. |
| Result | 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. |
| Result | 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 Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007. |
| 41343184 | Derived | Gharzai LA, Morris E, Schipper MJ, Kidwell KM, Nguyen-Tan PF, Rosenthal DI, Gillison ML, Jordan RC, Garden AS, Koyfman SA, Caudell JJ, Blakaj DM, Dunlap NE, Krempl GA, Longo JM, Jones CU, Gensheimer MF, Galloway TJ, DeMora L, Le QT, Shah JL, Suresh K, Mierzwa M. Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2026 Feb 1;152(2):144-153. doi: 10.1001/jamaoto.2025.4203. |
| 31420360 | Derived | Mell LK, Shen H, Nguyen-Tan PF, Rosenthal DI, Zakeri K, Vitzthum LK, Frank SJ, Schiff PB, Trotti AM 3rd, Bonner JA, Jones CU, Yom SS, Thorstad WL, Wong SJ, Shenouda G, Ridge JA, Zhang QE, Le QT. Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer. Clin Cancer Res. 2019 Dec 1;25(23):7078-7088. doi: 10.1158/1078-0432.CCR-19-1832. Epub 2019 Aug 16. |
| 30548235 | Derived | Beitler JJ, Switchenko JM, Dignam JJ, McDonald MW, Saba NF, Shin DM, Magliocca KR, Cassidy RJ, El-Deiry MW, Patel MR, Steuer CE, Xiao C, Hudgins PA, Aiken AH, Curran WJ Jr, Le QT. Smoking, age, nodal disease, T stage, p16 status, and risk of distant metastases in patients with squamous cell cancer of the oropharynx. Cancer. 2019 Mar 1;125(5):704-711. doi: 10.1002/cncr.31820. Epub 2018 Dec 11. |
| 25488965 | Derived | Wuthrick EJ, Zhang Q, Machtay M, Rosenthal DI, Nguyen-Tan PF, Fortin A, Silverman CL, Raben A, Kim HE, Horwitz EM, Read NE, Harris J, Wu Q, Le QT, Gillison ML. Institutional clinical trial accrual volume and survival of patients with head and neck cancer. J Clin Oncol. 2015 Jan 10;33(2):156-64. doi: 10.1200/JCO.2014.56.5218. Epub 2014 Dec 8. |
| 25366680 | Derived | Nguyen-Tan PF, Zhang Q, Ang KK, Weber RS, Rosenthal DI, Soulieres D, Kim H, Silverman C, Raben A, Galloway TJ, Fortin A, Gore E, Westra WH, Chung CH, Jordan RC, Gillison ML, List M, Le QT. Randomized phase III trial to test accelerated versus standard fractionation in combination with concurrent cisplatin for head and neck carcinomas in the Radiation Therapy Oncology Group 0129 trial: long-term report of efficacy and toxicity. J Clin Oncol. 2014 Dec 1;32(34):3858-66. doi: 10.1200/JCO.2014.55.3925. Epub 2014 Nov 3. |
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients who did not withdraw consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Fractionation RT + Cisplatin | Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients. |
| BG001 | Accelerated Fractionation RT + Cisplatin | Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Eligible patients who did not withdraw consent. | Posted | Number | 95% Confidence Interval | percentage of patients | 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. |
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| 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. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| 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. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| 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. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| 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. | Eligible patients who did not withdraw consent | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| 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). | Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months. | Posted | Mean | Standard Error | score on a scale * months | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. |
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| 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). | Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months. | Posted | Mean | Standard Error | score on a scale * months | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. |
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| 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). | Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months. | Posted | Mean | Standard Error | score on a scale * months | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. |
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| 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). | Eligible participants who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and one year. | Posted | Mean | Standard Error | score on a scale * months | Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment. |
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| Secondary | Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes | No assays were performed and no data were collected for this outcome measure. | Posted | From randomization to date of death or last follow-up |
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| Secondary | Correlation of COX-2 With Outcomes | No assays were performed and no data were collected for this outcome measure. | Posted | From randomization to date of death or last follow-up |
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|
Not provided
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Fractionation RT + Cisplatin | Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients. | 293 | 361 | 360 | 361 | ||
| EG001 | Accelerated Fractionation RT + Cisplatin | Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients. | 279 | 360 | 356 | 360 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphatics-Other | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Packed red blood cell transfusion | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Circulatory or cardiac-Other | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Endocrine-Other | Endocrine disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Larynx: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Mucous Membrane: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: dysphagia | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: tongue edema | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pancreatitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Salivary gland disorder NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis/pharyngitis for BMT | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Tracheo-oesophageal fistula NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: pain | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Culture wound positive | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Implant infection | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Blood alkaline phosphatase NOS increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Cardiac troponin T increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Metabolic-Other | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypoglycaemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Joint, muscle, or bone-Other | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bone: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Amnesia NEC | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dizziness (exc vertigo) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Headache NOS | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemorrhagic stroke | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Brain: NOS | Nervous system disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Spinal Cord: NOS | Nervous system disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Neurologic-Other | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vasovagal attack | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: airway obstruction | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: pharyngeal bleed | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: stenosis of airway | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Other: upper airway obstruction | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hemorrhage-Other | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: arteritis | Vascular disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Thrombosis NOS | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Visceral arterial ischaemia | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hearing-Other | Ear and labyrinth disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Larynx: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Mucous Membrane: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Salivary Gland (xerostomia, taste impairment) | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Radiation mucositis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Salivary gland disorder NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Edema NOS | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other: NOS | General disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Skin(within RT field): NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS | Injury, poisoning and procedural complications | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase NOS increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Metabolic-Other | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood albumin decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Joint, muscle, or bone-Other | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bone: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Joint: NOS | Musculoskeletal and connective tissue disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Spinal Cord: NOS | Nervous system disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Depression NEC | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Insomnia NEC | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Skin-Other | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
|
Local-regional failure and disease-free survival were additionally analyzed with the definition of failure used in the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group and the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) Collaborative Group publications. These modified outcome measures are labeled "Alternate Definition".
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | SeiferheldW@nrgoncology.org |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|
|
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
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Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients. |
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