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To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated dose escalated VMAT | Experimental | Hypofractionated dose escalated VMAT radiotherapy |
|
| Conventional concurrent chemoradiation | No Intervention | Conventional concurrent chemoradiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated dose escalated VMAT | Radiation | measure the local control, progression free survival and overall survival |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control in the two arms | Local control by RECIST criteria | 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| The progression free survival in the two arms | The time (in months) from the end of radiotherapy to the date of first progression | 33 months |
| The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0
| 33 months |