Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
|ClinicalTrials.gov Identifier: NCT00409331|
Recruitment Status : Terminated (Study terminated by Principal Investigator; no patients completed study.)
First Posted : December 8, 2006
Results First Posted : January 18, 2010
Last Update Posted : August 7, 2012
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.
To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:
- When the mean dose is < 24-26 Gy (shift recovery time to left)
- When the mean dose is > 24-26 Gy (DVH shift)
To observe mucositis in the following lower dose RT areas:
- Upper lip
- Lower lip
- Right cheek
- Left cheek
- Right ventral and lateral tongue
- Left ventral and lateral tongue
- Floor of the mouth
- Soft palate
- Hard palate.
- To observe the incidence and patterns of occipital scalp epilation;
- To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
- To further evaluate the safety profile of amifostine in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Amifostine Procedure: Intensity- Modulated Radiation Therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: IMRT + Amifostine
Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
Other Name: EthyolProcedure: Intensity- Modulated Radiation Therapy
2.0 to 2.2 Gy delivered in 30 fractions
Other Name: IMRT
- 12-month Clinically Relevant Salivary Flow (CRSF) [ Time Frame: 12 months ]Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409331
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mark Chambers, MD||M.D. Anderson Cancer Center|