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NCT00409331 · ClinicalTrials.gov registry record · Phase 2
Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00409331: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00409331 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00409331, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
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: 1. 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) 2. 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. 3. To observe the incidence and patterns of occipital scalp epilation; 4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and 5. To further evaluate the safety profile of amifostine in this patient population.
Primary Outcome
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.
Interventions
- DRUG Amifostine
- PROCEDURE Intensity- Modulated Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
Why NCT00409331 stopped before completion
NCT00409331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Amifostine is the first listed.
NCT00409331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00409331 about?
NCT00409331 is a clinical study titled "Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment". 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: 1. To establish a parotid gland dose volume histogram (DVH) versus measured fl...
What is the current status of trial NCT00409331?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2006-12. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00409331?
The interventions under investigation include: Amifostine (DRUG), Intensity- Modulated Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00409331?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00409331's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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