ClinicalTrials.gov record
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
ClinicalTrials.gov ID: NCT00113399
Public ClinicalTrials.gov record NCT00113399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
Study identification
- NCT ID
- NCT00113399
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- filgrastim Biological
- cisplatin Drug
- docetaxel Drug
- fluorouracil Drug
- paclitaxel Drug
- radiation therapy Radiation
Biological · Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2005
- Primary completion
- Jan 31, 2009
- Completion
- Not listed
- Last update posted
- Jul 1, 2013
Started 2005
United States locations
- U.S. sites
- 125
- U.S. states
- 28
- U.S. cities
- 99
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | — |
| St. Joseph's Mercy Cancer Center | Hot Springs | Arkansas | 71913 | — |
| Auburn Radiation Oncology | Auburn | California | 95603 | — |
| Radiation Oncology Centers - Cameron Park | Cameron Park | California | 95682 | — |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | — |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona | California | 91767 | — |
| Radiation Oncology Center - Roseville | Roseville | California | 95661 | — |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | — |
| University of California Davis Cancer Center | Sacramento | California | 95817 | — |
| Mercy General Hospital | Sacramento | California | 95819 | — |
| Solano Radiation Oncology Center | Vacaville | California | 95687 | — |
| Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton | Florida | 33486 | — |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | — |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | — |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | — |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405 | — |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | 62002 | — |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | — |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | — |
| Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields | Illinois | 60461 | — |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | — |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | — |
| St. John's Cancer Center at St. John's Medical Center | Anderson | Indiana | 46016 | — |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | — |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | — |
| Howard Community Hospital at Howard Regional Health System | Kokomo | Indiana | 46904 | — |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | — |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | — |
| Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | 47374 | — |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana | 71130-3932 | — |
| MaineGeneral Medical Center - Waterville Campus | Waterville | Maine | 04901 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | — |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | — |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | — |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph | Michigan | 49085 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63701 | — |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri | 63701 | — |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | — |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | — |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | — |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | — |
| Deaconess Billings Clinic - Downtown | Billings | Montana | 59107-7000 | — |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | — |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire | 03431 | — |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | — |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | — |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | — |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | 08360 | — |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees Township | New Jersey | 08043 | — |
| Long Island College Hospital | Brooklyn | New York | 11201 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | — |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | — |
| Lenoir Memorial Cancer Center | Kinston | North Carolina | 28501 | — |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | — |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | — |
| Cancer Care Center at Medcenter One Hospital | Bismarck | North Dakota | 58501 | — |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | — |
| St. Alexius Medical Center | Bismarck | North Dakota | 58502 | — |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | — |
| Akron City Hospital | Akron | Ohio | 44309-2090 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | — |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | — |
| CCOP - Dayton | Dayton | Ohio | 45429 | — |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | — |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | — |
| Lima Memorial Hospital | Lima | Ohio | 45804 | — |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43623 | — |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | — |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | — |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | — |
| Firelands Regional Medical Center | Sandusky | Ohio | 44870 | — |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | — |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | — |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | — |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | — |
| Cancer Treatment Center | Wooster | Ohio | 44691 | — |
| United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB | Ohio | 45433-5529 | — |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Mercy Fitzgerald Hospital | Darby | Pennsylvania | 19023 | — |
| Alle-Kiski Medical Center | Natrona Heights | Pennsylvania | 15065 | — |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | — |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | — |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | — |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | — |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | — |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57117-5039 | — |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | — |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | — |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | — |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | — |
| Latter Day Saints Hospital | Salt Lake City | Utah | 84143 | — |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | — |
| Norris Cotton Cancer Center - North | Saint Johnsbury | Vermont | 05819 | — |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | — |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin | 53051 | — |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | — |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | 53405 | — |
| University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | — |
| West Allis Memorial Hospital | West Milwaukee | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00113399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2013 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00113399 live on ClinicalTrials.gov.