Oropharyngeal Function After Radiotherapy With IMRT
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|ClinicalTrials.gov Identifier: NCT00506324|
Recruitment Status : Terminated (Physician deceased)
First Posted : July 25, 2007
Last Update Posted : July 14, 2015
|First Submitted Date||July 20, 2007|
|First Posted Date||July 25, 2007|
|Last Update Posted Date||July 14, 2015|
|Study Start Date||June 2006|
|Actual Primary Completion Date||June 2014 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures
||percent oral intake [ Time Frame: 12 months post-treatment completion ]
The percent of nutrition taken by mouth
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00506324 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||normal diet [ Time Frame: 12 months post-treatment completion ]
The patient has a normal diet when he or she includes all consistencies (thin liquid, thick liquid, pudding, pureed, soft mechanical, hard mechanical)
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Oropharyngeal Function After Radiotherapy With IMRT|
|Official Title||Oropharyngeal Function After Radiotherapy With IMRT|
|Brief 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 as well as assessment of disease status and quality of life scales. Head and neck cancer is a severe problem that affects public health. Most current treatments are a combination of radiotherapy with chemotherapy, which can result in severe swallowing problems which may make patients unwilling to accept this type of treatment. This project attempts to quantify the swallow problems associated with this specific treatment and the effects of interventions for these swallow problems.|
A. Subjects One hundred and twenty-five patients with disease Stages III or IV squamous cell cancers of the oral cavity, larynx or pharynx will serve as subjects.
B. Intensity Modulation and Radiotherapy Guidelines Anatomical data that is required for the planning process is acquired using a Philip's AcQSim CT simulation system. The immobilized patient is squared up relative to the bore of the Picker PQ2000S CT scanner using the ceiling and side lasers of the system. A scout view is obtained so that the superior and inferior borders of the volume study can be determined. Forty seconds prior to the commencement of image data acquisition contrast media (125 cc of Ultravist 300) is power injected at the rate of 1.3-2.0 cc/sec using a Liebel-Flarsheim device. The CT data set is acquired with 3 mm slice thickness and spacing using the spiral mode of the scanner. While the patient is on the table, the images are transferred to the VoxelQ work station that is running AcQSim software version 4.1.1. Before the patient is released a reference isocenter is established and recorded in the AcQSim system and marked on the face mask using the isocenter locating lasers of the CT simulator, if not already indicated by radio-opaque fiducials.
The physicians then outline target volumes, GTVs and CTVs, as per ICRU 50 guidelines and outline critical structures such as the brain stem, spinal cord, salivary glands, optic apparatus, etc. After this has been done, the image and structure data is transferred to either of two treatment planning work stations: the NOMOS Corvus system running software version 5.0 or the ADAC Pinnacle RTP system running software version 6.2b. A planning target margin (PTV) is added to take into account organ motion and setup uncertainty. Lateral and Anterior-Posterior digitally reconstructed radiographs (DRRs) that demonstrate the location of isocenter are produced from the AcQSim system so that correct patient positioning can be confirmed prior to the commencement of treatment.
The prescription for the target(s) defines the dose goal for the treatment, the minimal acceptable dose and percent volume that can be under dosed and the maximum acceptable dose. The prescription for radio sensitive structures sets the nominally allowed dose, the percent volume that can be overdosed, the maximum tolerable dose and the minimum dose below which no radiation damage can be observed. These specifications, for various targets and critical structures, translate into defining three points on a dose volume histogram (DVH) curve for each tissue type. The Corvus system computes the optimal beam intensity maps using a simulated annealing algorithm whereas the ADAC system uses a sequential quadratic search method to minimize a quadratic objective function, which is constructed from a set of dose-based or dose-volume-based objectives for individual regions of interest. Delivery of the dose as prescribed by the idealized maps is accomplished by using step and shoot IMRT at both institutions. In this method the beam direction incident on the patient along with field size and collimator angle is determined by the treatment planner before the software designs the IMRT intensity maps. Therefore it is important to choose beam geometries carefully so as to maximize exposure to the target and minimize exposure to critical structures as visualized in the beam's eye view. The IMRT beams are created by utilizing a standard 80 cm leaf MLC on an Elekta Sli linear accelerator.
Radiotherapy Guidelines for the proposed study:
Radiation Targets and Dose Specifications:
The following is the definition of targets. The radiation doses will be delivered as specified in the protocol:
Low Neck: The midjugular, low jugular, and supraclavicular nodes can be treated either with IMRT or alternatively with an AP field that is beam split to the IMRT fields. This will be at the discretion of the treating physician. If an IMRT approach is not used, then it will not be necessary to submit the DVHs for this PTV. However, if an IMRT approach is used, then it will be necessary to generate DVHs for this PTV. Radiation doses will be as in the attached protocol.
Neck Nodes: Guidelines for anatomic boundaries and CT-based delineation of neck nodes will be as per consensus Atlas on RTOG website (www.RTOG.org → Researcher → H/N Atlas).
Normal Tissues: The appropriate normal organs will be contoured. Dose Volume Histograms (DVH) will be generated. An attempt will be made to keep the maximum radiation doses to the following organs as follows; since the radiation to these structures will be at a lower fraction per day and the maximum doses to partial volumes only, we believe these are acceptable dose levels.
Brain Stem: 54 Gy Optic Nerve/Chiasm: 55 Gy Spinal Cord: 45 Gy Mandible/TM Joint: 70 Gy or 1cc of the PTV not to exceed 75 Gy Larynx 70 Gy
Parotid Glands: Attempt will be to achieve mean dose 26 Gy in at least one gland or at least 20cc of the combined volume of both parotid glands will receive 20 Gy or at least 50% of the gland will receive 30 Gy (should be achieved in at least one gland).
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||One hundred and twenty-five patients with disease Stages III or IV squamous cell cancers of the oral cavity, larynx or pharynx will serve as subjects. No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow, and no preexisting swallowing disorder.|
|Condition||Head and Neck Neoplasms|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Actual Study Completion Date||June 2014|
|Actual Primary Completion Date||June 2014 (Final data collection date for primary outcome measure)|
|Ages||21 Years to 79 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||R01DC007659-01A1( U.S. NIH Grant/Contract )
R01DC007659 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Northwestern University|
|Study Sponsor||Northwestern University|
|Collaborators||National Institute on Deafness and Other Communication Disorders (NIDCD)|
|PRS Account||Northwestern University|
|Verification Date||July 2015|