- * Have recently diagnosed (\< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) are eligible
- * Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.
- * Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin regimen administered weekly (100 mg/m2)
- * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- * CRP \< 80 mg/L
- * Have adequate hematopoietic, hepatic, and renal function at the screening visit
Oral Mucositis
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
NCT01403064 | PHASE 2 | INTERVENTIONAL
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
Trial Information
If interested, contact clinicaltrials@cslbehring.com for more information
CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy
Morton Plant Mease Health Care
Clearwater,Florida,United States,33756
Dana Farber Cancer Institute
Boston,Massachusetts,United States,02215
Karmanos Cancer Center
Detroit,Michigan,United States,48201
Detroit Clinical Research Center
Farmington Hills,Michigan,United States,48336
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack,New Jersey,United States,07601
University of New Mexico Cancer Center
Albuquerque,New Mexico,United States,87106
Mount Sinai School of Medicine
New York,New York,United States,10029
SUNY Upstate Medical University
Syracuse,New York,United States,13210
Temple University Hospital
Philadelphia,Pennsylvania,United States,19140
Spartanburg Regional Medical Center
Spartanburg,South Carolina,United States,29303
Cancer Specialists of Southern Texas
Corpus Christi,Texas,United States,78412
University of Texas Southwestern Medical Center
Dallas,Texas,United States,75390
VA Puget Sound Health Care Syatem
Seattle,Washington,United States,98108
St. Vincent's Hospital
Darlinghurst,New South Wales,Australia,2010
Calvary Mater Newcastle
Waratah,New South Wales,Australia,2298
Royale Brisbane and Women's Hospital
Herston,Queensland,Australia,4029
Princess Alexandra Hospital
Woolloongabba,Queensland,Australia
Adelaide Radiotherapy Centre
Adelaide,South Australia,Australia,5037
Royal Adelaide Hospital
Adelaide,South Australia,Australia
LKH Graz, HNO Ambulanz
Graz,Austria
Univ. Klinik fur Innere Medizin III
Salzburg,Austria,5020
Hanusch Krankenhaus
Vienna,Austria,1140
Cancer Centre of Southeastern Ontario
Kingston,Ontario,Canada,K7L5P9
MaisonneuveRosemont Hospital
Montreal,Quebec,Canada,H1T2M4
CHUQL'HotelDieu de Quebec
Quebec,Canada,G1R2J6
Universitatsklinikum Freiburg
Freiburg,Germany,79106
University Medical School, Saarland
Homburg,Germany,66424
Uniklinik Koln
Koln,Germany,50924
A.O. San Paolo Polo Universitario
Milan,Italy,20142
Istituto Nazionale dei tumari
Milan,Italy
Azienda OspedalieroUniversitaria Santa Maria della Misericordia
Udine,Italy,33100
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov