Clinical Trial Details

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Study ID 20060212
Investigator
Cristiane Takita, MD,   University of Miami Sylvester Comprehensive Cancer Center
Title 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
Interventions Radiation: Postop IMRT for head/neck cancer
Device: CT for Radiation Treatment Planning
Phase N/A
Purpose Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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
  • Study Location
    University of Miami Sylvester Comprehensive Cancer Center
    Miami, Florida, 33136
    Contact Cristiane Takita, MD
    305-243-4255
    CTakita@med.miami.edu
    Information objtained from ClinicalTrials.gov, on 10/22/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT02003482


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