Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best treatment.

Detailed Description
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I. To conduct a clinical imaging study utilizing three novel in-room imaging systems: Oblique Brainlab ExacTrac images, Orthogonal Varian kilovoltage (kV) On-board Imaging (OBI) image, and Varian cone-beam computed tomography (CBCT) imaging to assess their performance in reducing inter- and intrafractional setup errors, relative to weekly megavoltage (MV) electronic portal imaging device (EPID) images, using both bony landmarks and soft tissue changes for head and neck cancer (HNC) patients undergoing external beam radiation therapy (RT). II. To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck (HN) area relative to conventional high resolution contrast enhanced fan-beam computed tomography (CT) (FBCT) as a standard. III. To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy. IV. To quantify soft tissue changes during an entire course of radiotherapy (e.g. tumor shrinkage) using daily CBCT imaging. V. To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images, for offline adaptive replanning of HNC patients using available planning tools. VI. To quantify the benefits of adaptive image-guided radiotherapy (IGRT) in HN patients in terms of target coverage and normal tissue avoidance. VII. To determine the feasibility of mounting a phase I/II trial to assess the clinical benefits of image-guided adaptive radiotherapy (IGART) in terms of acute and late toxicities and tumor control. VIII. To build a HNC patient database for future validation of IGART processes using deformable image registration and Virtual Clinical Trials (VCTs). OUTLINE: Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-dimensional (2-D) x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

Official Title
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Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: cone-beam computed tomography
* Procedure: radiography
* Procedure: radiography
* Procedure: radiography
* Procedure: electronic portal imaging
* Radiation: image-guided adaptive radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic confirmation of head and neck malignancy Patients who will be treated with definitive radiation therapy or concurrent chemoradiation therapy Gross tumor volume (GTV) must be visible on CT All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: Pregnant or nursing women may not participate; women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method Prior treatment with radiation therapy to the head and neck Serum creatinine > 1.5 and/or Blood urea nitrogen [BUN] > 25 Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for this malignancy Patients with known syndromes expected to alter radiosensitivity (e.g. ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus [HIV]/acquired immunodeficiency deficiency syndrome [AIDS]) may not participate

Ages Eligible for Study
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Minimum Age: 21 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: in-room imaging systems<br>Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART. | Procedure: computed tomography<br>* Undergo FBCT<br>* Other names: tomography, computed;Procedure: cone-beam computed tomography<br>* Undergo dual CBCT<br>Procedure: radiography<br>* Undergo 2-D x-ray with Varian kV OBI<br>* Other names: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging;Procedure: radiography<br>* Undergo 2-D x-ray with Brain Lab ExacTrac<br>* Other names: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging;Procedure: radiography<br>* Undergo 2-D x-ray with Varian MV OBI<br>* Other names: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, X-Ray Imaging;Procedure: electronic portal imaging<br>* Undergo EPID imaging<br>* Other names: EPI;Radiation: image-guided adaptive radiation therapy<br>* Undergo IGART<br>* Other names: IGART, image-guided adaptive radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan. | up to 7 weeks | 
| Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10% |  | Up to 7 weeks | 
| Greater Than or Equal to 5% Variation of Normal Tissue Toxicity |  | Up to 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lip, Oral Cavity and Pharynx, Larynx