Head and Neck Cancer
Conditions
Brief summary
Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer. The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy. The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research. The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study. In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.
Interventions
OTHERCone Beam Computed Tomography (CT) Scan
Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of all ages ≥18, both sexes, and all races will be included in this study. Pregnant females will be excluded. No other special classes of subjects (i.e., prisoners) will be entered. * Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck. * Patients must be recommended treatment with definitive radiation therapy with concurrent chemotherapy, but without prior surgical resection of the primary tumor or lymph nodes * Patients must be recommended a treatment course of at least 30 radiation fractions * Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware that undergoing cone beam CT of the head and neck is voluntary and has potential risks.
Exclusion criteria
* Patients must not have a history of prior radiation to the head or neck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Movement of Normal Tissue | approximately 7 weeks | The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement. |
| Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 24 months | Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Image Quality | 36 months | Use acquired data to further improve cone beam CT reconstruction techniques and image quality. |
| The Median Delivered Dose of Radiation to the Parotid Gland | 7 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cone Beam CT For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completed Treatment Off Study | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cone Beam CT |
|---|---|
| Age, Continuous | 57 years |
| Disease Site Base of Tongue | 9 participants |
| Disease Site Tonsil | 9 participants |
| N Stage N0 | 1 participants |
| N Stage N1 | 0 participants |
| N Stage N2a | 1 participants |
| N Stage N2b | 10 participants |
| N Stage N2c | 4 participants |
| N Stage N3 | 2 participants |
| Pre-Treatment Weight | 203 lb |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 16 Participants |
| T Stage T1 | 2 participants |
| T Stage T2 | 10 participants |
| T Stage T3 | 5 participants |
| T Stage T4 | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
Primary
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Time frame: 24 months
Population: 36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | Baseline | -0.26 correlation coefficient |
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 3 Months | -0.42 correlation coefficient |
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 6 Months | -0.57 correlation coefficient |
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 12 Months | -0.35 correlation coefficient |
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 18 Months | -0.42 correlation coefficient |
| Cone Beam CT | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | 24 Months | -0.60 correlation coefficient |
Primary
Rate of Movement of Normal Tissue
The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
Time frame: approximately 7 weeks
Secondary
Improvement of Image Quality
Use acquired data to further improve cone beam CT reconstruction techniques and image quality.
Time frame: 36 months
Secondary
The Median Delivered Dose of Radiation to the Parotid Gland
Time frame: 7 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cone Beam CT | The Median Delivered Dose of Radiation to the Parotid Gland | 32.4 Gy |