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NCT00506324 · ClinicalTrials.gov registry record
Oropharyngeal Function After Radiotherapy With IMRT
A clinical trial, sponsored by Northwestern University.
- Terminated
- Registry status
- 125
- Enrollment target
NCT00506324: Clinical Trial study, sponsored by Northwestern University.
NCT00506324 is a clinical trial that was terminated before completion, run by Northwestern University. The registered enrollment target is 125 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506324 was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- 125 participants
- Enrollment target
Study Summary
This project defines the effect on swallowing of intensity modulation during radiotherapy in an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies. The specific aims are: 1) define the physiologic effects of chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including the cervical esophagus and the rate at which patients return to oral intake; 2) document the acute toxicities, late complications, locoregional failure and survival, and the relationship between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the patient's swallowing mechanism can compensate for physiologic deficits in swallowing by introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers and/or volume, presence of an esophageal stricture and the duration of success of dilatation depends on radiation dose volume to specific structures in the head and neck; 5) define the relationship of tongue base pressure to development of esophageal stricture. Patients will be accrued from Northwestern University and University of Chicago. Effects are defined in terms of swallowing function, morbidity, toxicity and survival. Other outcome measures are the maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation. At each assessment, patients will receive a videofluoroscopic assessment of swallowing utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis
Primary Outcome
The percent of nutrition taken by mouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2006-06 |
| Est. Completion | 2014-06 |
Why NCT00506324 stopped before completion
NCT00506324 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00506324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00506324 about?
NCT00506324 is a clinical study titled "Oropharyngeal Function After Radiotherapy With IMRT". This project defines the effect on swallowing of intensity modulation during radiotherapy in an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies...
What is the current status of trial NCT00506324?
This trial is currently terminated. The enrollment target is 125 participants. The study started on 2006-06. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT00506324?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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