Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Conditions
Head and Neck Cancer - Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Intensity modulated radiation therapy, IMRT, Anatomic Changes, Postoperative, Unresectable
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Postop IMRT for head/neck cancer Type: Radiation
Name: CT for Radiation Treatment Planning Type: Device
Overall Status
Recruiting
Summary
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:

- If gross total resection is performed it must be completed within 7 weeks of registration

- Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)

- Pretreatment evaluations required for eligibility include:

- History and physical examination within four weeks prior to study entry

- Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation

- Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment

- Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required

- 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:

- Histology positive for melanoma.

- Gross (visible or palpable) disease left after surgery.

- Less than gross total resection or patients requiring staged surgery.

- Prior head and neck radiotherapy.

- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
Location
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Status: Recruiting
Contact: Cristiane Takita, MD - 305-243-4255 - CTakita@med.miami.edu
Start Date
March 2006
Completion Date
March 2016
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page