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| Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004227 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: cetuximab Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| Drug Information available for: | Cetuximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck |
| Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by Karnofsky performance status (60-80% vs 90-100%), nodal stage (N0 vs N+), tumor stage (T1-3 vs T4), and radiotherapy schedule (concurrent boost vs once daily vs twice daily).
Patients are randomized to 1 of 2 treatment arms:
Arm I: Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups:
Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8 weeks after the completion of radiotherapy.
Quality of life is assessed before initiation of study therapy, at 8 weeks, and then every 4 months for 1 year.
Patients are followed at 8 weeks, every 4 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 416 patients (208 per arm) will be accrued for this study within approximately 5 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New Jersey | |||||
| ImClone Systems, Incorporated | |||||
| Somerville, New Jersey, United States, 08876 | |||||
| Kimball Medical Center | |||||
| Lakewood, New Jersey, United States, 08701 | |||||
| Monmouth Medical Center | |||||
| Long Branch, New Jersey, United States, 07740-6395 | |||||
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
| National Cancer Institute (NCI) |
| Study Chair: | James A. Bonner, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78.
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Bonner JA, Harari PM, Giralt J, et al.: The relationship of cetuximab-induced rash and survival in patients with head and neck cancer treated with radiotherapy and cetuximab. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-120, S73, 2005.
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Bonner JA, Girald J, Harari PM, et al.: Phase III evaluation of radiation with and without cetuximab for locoregionally advanced head and neck cancer. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-31, S147-8, 2004. Available online. Last accessed February 3, 2005.
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| Study ID Numbers: | CDR0000067468, UAB-9901, IMCL-CP02-9815, NCI-G99-1657 |
| First Received: | January 28, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004227 |
| Health Authority: | United States: Federal Government |
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