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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postop IMRT for Head/Neck cancer | CT for Radiation Treatment Planning |
| |
| Chemo/IMRT for bulky Head/Neck cancer | CT for Radiation Treatment Planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postop IMRT for head/neck cancer | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 weeks |
| Length of Time Required for Replanning of Radiation Therapy |
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Inclusion Criteria:
AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:
Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
Pretreatment evaluations required for eligibility include:
Patients must be ≥ 18 years of age.
Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in accordance with local regulations, whichever is more sensitive).
Patients must sign a study-specific informed consent form prior to registration.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane Takita, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| CT for Radiation Treatment Planning | Device | 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 |
|
|
To estimate what the appropriate time course should be for re-planning of radiation therapy if it is deemed necessary. |
| 7 weeks |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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