Cancer of Head and Neck
Conditions
Brief summary
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
Detailed description
The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.
Interventions
RADIATIONconcurrent chemo + IGRT
RADIATIONneoadjuvant chemo + IGRT
Sponsors
Beth Israel Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2 * Patients should meet at least one of the following criteria: 1. Locally advanced cancer (T3-T4 and/or N2-N3) 2. Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem 3. Significant expected weight loss.
Exclusion criteria
* Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes. * Poor renal function (inability to undergo a CT with IV contrast) * Previous radiation therapy to the head and neck. * Inability to tolerate prolonged immobilization. * Children and women who are pregnant or decline to use contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical patient response | From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years). | This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life | During radiation therapy (7-9 weeks) | This will be assessed using the: Fact Head & Neck form at baseline, and weekly throughout radiation treatment. |
Countries
United States
Outcome results
None listed