Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer

Completed

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

In brief

Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.

Key facts

Study ID

NCT02003482

Run by

University of Miami

People needed

39

Starts

2006-05-09

Expected to finish

2018-03-26

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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