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Sponsors and Collaborators: |
M.D. Anderson Cancer Center MedImmune LLC |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00409331 |
Primary Objective:
To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.
Secondary Objectives:
To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
To observe mucositis in the following lower dose RT areas:
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: Amifostine Procedure: Intensity- Modulated Radiation Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing |
Enrollment: | 3 |
Study Start Date: | December 2006 |
Study Completion Date: | January 2009 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IMRT + Amifostine: Experimental
Intensity-Modulated Radiation Therapy (IMRT) + Amifostine
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Drug: Amifostine
500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
Procedure: Intensity- Modulated Radiation Therapy
2.0 to 2.2 Gy delivered in 30 fractions
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Mark Chambers, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Mark Chambers, DMD/Assoc. Professor ) |
Study ID Numbers: | 2006-0234 |
Study First Received: | December 7, 2006 |
Last Updated: | August 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00409331 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Head and Neck Cancer HNSCC Submandibular and Sublingual Salivary Sparing |
Amifostine Ethyol Radiation Therapy |
Radiation-Protective Agents Amifostine Head and Neck Neoplasms Carcinoma, Squamous Cell of Head and Neck |
Radiation-Protective Agents Neoplasms Neoplasms by Site Amifostine |
Head and Neck Neoplasms Physiological Effects of Drugs Protective Agents Pharmacologic Actions |