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| ID | Type | Description | Link |
|---|---|---|---|
| 18826 | Other Identifier | REB |
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Poor Accrual
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| Name | Class |
|---|---|
| London Regional Cancer Program, Canada | OTHER |
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For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical patients | Active Comparator | This group will consist of 15 patients with locally advanced HNSCC of the oral cavity, larynx or hypopharynx presenting with adenopathy ≥ 1 cm where the recommended treatment is surgical resection of the primary malignancy with bilateral neck dissection. These patients will receive a DCE-CT scan of the head and neck prior to surgery. |
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| Chemoradiation Patients | Active Comparator | This group will consist of 15 patients with locally advanced HNSCC with lymph nodes ≥3 cm in which chemoradiotherapy is the primary treatment as per standard of care. This group will be composed of patients with a primary malignancy originating in the nasopharynx, oropharynx, hypopharynx or larynx. Pre-treatment DCE-CT of neck will be obtained. The standard therapy, radiation and chemotherapy, will be administered and the patients will have standard follow up. A post-treatment DCE-CT of neck will be obtained 8-10 weeks after treatment along with standard CT neck. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Contrast Enhanced CT scan | Radiation | The neck will be scanned using 120 kVp, 50 mAs, 8 x 5 mm slices at intervals of 2.8 - 3.0 s for 3 min. Contrast (e.g. Visipaque 320) at a dosage of 0.7 ml/kg is injected at 4 ml/s through an antecubital vein after a delay of 6 s from start of scanning. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy | 8-10 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery | Approximately 2-6 weeks after enrollment |
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Inclusion Criteria:
Age 18 or older
Willing to provide informed consent
ECOG performance status 0-2
Histologically confirmed squamous cell carcinoma (includes variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head and neck
Tumor stage: Any (T1-T4)
Nodal stage:
Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon), with recommendation for definitive chemoradiation therapy (n=15) or surgery (n=15)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Palma, MD, MSc, PhD | London Regional Cancer Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Program | London | Ontario | N6A4L6 | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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