An observational study in Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by University of Miami · Observational
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 39 is below the median of 100 across 268 observational studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Patients with pathologic stage I-IV cancers of the head and neck (site of tumor origin nasopharynx, parotid, oral cavity, oropharynx, larynx, or hypopharynx,) either following gross total resection and requiring postoperative XRT for high-risk features or undergoing definitive concurrent chemo-radiation.
AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:
Pretreatment evaluations required for eligibility include:
Exclusion Criteria:
CT for Radiation Treatment Planning
Radiation: Postop IMRT for head/neck cancer · Device: CT for Radiation Treatment Planning
CT for Radiation Treatment Planning
Radiation: Postop IMRT for head/neck cancer · Device: CT for Radiation Treatment Planning
Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.
Also known as: IMRT
Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment
Also known as: CT Simulation
Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.
Time frame: 7 weeks
Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer
To determine whether patients undergoing standard IMRT for head and neck cancers require re-planning during the course of therapy, due to volumetric or dosimetric changes.
Time frame: 7 weeks
Length of Time Required for Replanning of Radiation Therapy
To estimate what the appropriate time course should be for re-planning of radiation therapy if it is deemed necessary.
Time frame: 7 weeks
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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