Adaptive Radiation Therapy for Head & Neck Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Radiation: concurrent chemo + IGRT
* Radiation: neoadjuvant chemo + IGRT


Participation Criteria
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Eligibility Criteria
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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: Locally advanced cancer (T3-T4 and/or N2-N3) Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: definitive radiation + concomitant chemo<br>Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment | Radiation: concurrent chemo + IGRT<br> <br> |
| Experimental: neoadjuvant chemo<br>Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment. | Radiation: neoadjuvant chemo + IGRT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical patient response | This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo. | From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient quality of life | This will be assessed using the: Fact Head & Neck form at baseline, and weekly throughout radiation treatment. | During radiation therapy (7-9 weeks) |