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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00846 | Registry Identifier | NCI | |
| HM11639 | Other Identifier | Virginia Commonwealth University IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| in-room imaging systems | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure | Undergo FBCT |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Evans, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University, Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Imaging Technology) | 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. computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cone-beam computed tomography | Procedure | Undergo dual CBCT |
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| radiography | Procedure | Undergo 2-D x-ray with Varian kV OBI |
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| radiography | Procedure | Undergo 2-D x-ray with Brain Lab ExacTrac |
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| radiography | Procedure | Undergo 2-D x-ray with Varian MV OBI |
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| electronic portal imaging | Procedure | Undergo EPID imaging |
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| image-guided adaptive radiation therapy | Radiation | Undergo IGART |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Imaging Technology) | 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. computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance. | Posted | Mean | Standard Deviation | mm | up to 7 weeks |
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| Primary | Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10% | No data analyzed due to staff leaving primary institution. | Posted | Up to 7 weeks |
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| Primary | Greater Than or Equal to 5% Variation of Normal Tissue Toxicity | No data analyzed due to staff leaving primary institution. | Posted | Up to 7 weeks |
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Adverse Event Reporting were collected up to 7 weeks while the patient was undergoing the course of radiation therapy. No adverse events occurred due to additional xray imaging from this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Imaging Technology) | 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. computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART | 1 | 16 | 7 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SEPSIS-ASSOCIATED ORGAN DYSFUNCTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Death not associated with CTCAE term - Sudden death. Cause of Death, SEPSIS-ASSOCIATED ORGAN DYSFUNCTION |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Below normal Glomerular filtration rate (GFR) | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | Metabolic/Laboratory, Glomerular filtration rate grade 1 and grade 2 |
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| Elevated Creatinine | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment | 3 events grade 1 and 4 events grade 2. |
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| Elevated Blood Urea Nitrogen (BUN) | Blood and lymphatic system disorders | CTCAE (Unspecified) | Non-systematic Assessment | Metabolic/Laboratory - Other (Specify, __) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Evans, Ph.D. | Virginia Commonwealth University | 804-628-0661 | jevans2@mcvh-vcu.edu |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| C562489 | Lymphoid Interstitial Pneumonia |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.
| 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. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance. | t-test, 2 sided | 1.00 | Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00. | Yes | Non-Inferiority or Equivalence | Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison. |
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