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 8/27/2014. 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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