Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer
Public ClinicalTrials.gov record NCT00360971. 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 Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Therapy With Concurrent Chemotherapy (Followed by Surgery for Selected Patients)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
Study identification
- NCT ID
- NCT00360971
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Interventions
- palifermin Biological
- cisplatin Drug
- placebo Other
- neck dissection Procedure
- radiation therapy Radiation
Biological · Drug · Other + 2 more
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
- Jul 2006 (Type not available)
- Primary completion
- May 2008 (Actual)
- Completion
- Feb 2009 (Actual)
- Last update posted
- Dec 26, 2017
2006 – 2009
United States locations
- U.S. sites
- 47
- U.S. states
- 18
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Auburn Radiation Oncology | Auburn | California | 95603 | — |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | — |
| Radiation Oncology Centers - Cameron Park | Cameron Park | California | 95682 | — |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | — |
| Enloe Cancer Center at Enloe Medical Center | Chico | California | 95926 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | — |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | — |
| Radiation Oncology Center - Roseville | Roseville | California | 95661 | — |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | — |
| Mercy General Hospital | Sacramento | California | 95819 | — |
| Torrance Memorial Medical Center | Torrance | California | 90509 | — |
| Solano Radiation Oncology Center | Vacaville | California | 95687 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Saint John's Cancer Center at Saint John's Medical Center | Anderson | Indiana | 46016 | — |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | — |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| CentraCare Clinic - River Campus | Saint Cloud | Minnesota | 56303 | — |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | — |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | — |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden | New Jersey | 08103 | — |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | 08360 | — |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | — |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27835-6028 | — |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | — |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | — |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | — |
| Cancer Treatment Center | Wooster | Ohio | 44691 | — |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | — |
| Sharon Regional Cancer Care Center- Hermitage | Hermitage | Pennsylvania | 16148 | — |
| Intercommunity Cancer Center | Monroeville | Pennsylvania | 15146 | — |
| Alle-Kiski Medical Center | Natrona Heights | Pennsylvania | 15065 | — |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Somerset Oncology Center | Somerset | Pennsylvania | 15501 | — |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | — |
| Johnson City Medical Center Hospital | Johnson City | Tennessee | 37604 | — |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | — |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | — |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00360971, 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 Dec 26, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00360971 live on ClinicalTrials.gov.