A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer

Conditions
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Locally Advanced Head and Neck Cancer

Intervention / Treatment
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* Radiation: Hypofractionated dose escalated VMAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤70 years old. Histopathologically confirmed squamous cell carcinoma of head and neck. Locally advanced tumors (T3-T4 &/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition). Patients not exposed to radical surgery for current disease. Performance status (ECOG) 2 or less. No associated co-morbidity with contraindication to chemotherapy. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L) Accepted renal functions. (BUN & serum creatinine <1.5x upper limit of normal value with normal GFR). Accepted liver functions. (total bilirubin and direct bilirubin < 1.5 x ULN & alanine aminotransferase and aspartate aminotransferase < 3 x ULN) Informed consent. Exclusion Criteria: Patients with distant metastatic lesions, as detected by imaging techniques. Patients with history of other head and neck malignancies. Patients with history of previous head and neck irradiation. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection. Women who are pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated dose escalated VMAT<br>Hypofractionated dose escalated VMAT radiotherapy | Radiation: Hypofractionated dose escalated VMAT<br>* measure the local control, progression free survival and overall survival<br>|
| No Intervention: Conventional concurrent chemoradiation<br>Conventional concurrent chemoradiation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control in the two arms | Local control by RECIST criteria | 33 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0 | 33 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionation, VMAT, head and neck cancer