Head and Neck Cancer
Conditions
Keywords
Lip, Oral Cavity and Pharynx, Larynx
Brief summary
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
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.
Interventions
PROCEDUREcomputed tomography
Undergo FBCT
PROCEDUREcone-beam computed tomography
Undergo dual CBCT
PROCEDUREradiography
Undergo 2-D x-ray with Varian kV OBI
PROCEDUREelectronic portal imaging
Undergo EPID imaging
Undergo IGART
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | up to 7 weeks | 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. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Diagnostic (Imaging Technology) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
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.
Time frame: up to 7 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthogonal Varian kV OBI Image | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Vertical shift | -1.2 mm | Standard Deviation 3.1 |
| Orthogonal Varian kV OBI Image | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Lateral shift | -1.5 mm | Standard Deviation 3.3 |
| Varian CBCT (Cone Beam CT) Imaging | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Vertical shift | -0.8 mm | Standard Deviation 3.4 |
| Varian CBCT (Cone Beam CT) Imaging | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Lateral shift | -1.1 mm | Standard Deviation 3.3 |
| Oblique Brainlab ExacTrac Images | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Vertical shift | -1.8 mm | Standard Deviation 3.2 |
| Oblique Brainlab ExacTrac Images | Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies | Lateral shift | 1.3 mm | Standard Deviation 3.9 |
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.p-value: 1t-test, 2 sided
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.p-value: 1t-test, 2 sided
Primary
Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%
Time frame: Up to 7 weeks
Population: No data analyzed due to staff leaving primary institution.
Primary
Greater Than or Equal to 5% Variation of Normal Tissue Toxicity
Time frame: Up to 7 weeks
Population: No data analyzed due to staff leaving primary institution.