Clinical trial NCT02003482: Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Official title: Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Keywords: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Intensity modulated radiation therapy
IMRT
Anatomic Changes
Postoperative
Unresectable
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
timeFrame: 7 weeks
Secondary outcomes:
measure: Number of Participants Requiring Re-Planning During the Course of IMRT for bulky and postoperative Head and Neck Cancer
timeFrame: 7 weeks
measure: Length of Time Required for Replanning of Radiation Therapy
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Cristiane Takita, MD
role: PRINCIPAL_INVESTIGATOR
References: