Locally Advanced Head and Neck Cancer
Conditions
Keywords
Hypofractionation, VMAT, head and neck cancer
Brief summary
To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer
Detailed description
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
Interventions
RADIATIONHypofractionated dose escalated VMAT
measure the local control, progression free survival and overall survival
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤70 years old. 2. Histopathologically confirmed squamous cell carcinoma of head and neck. 3. Locally advanced tumors (T3-T4 &/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition). 4. Patients not exposed to radical surgery for current disease. 5. Performance status (ECOG) 2 or less. 6. No associated co-morbidity with contraindication to chemotherapy. 7. Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L) 8. Accepted renal functions. (BUN & serum creatinine \<1.5x upper limit of normal value with normal GFR). 9. Accepted liver functions. (total bilirubin and direct bilirubin \< 1.5 x ULN & alanine aminotransferase and aspartate aminotransferase \< 3 x ULN) 10. Informed consent.
Exclusion criteria
1. Patients with distant metastatic lesions, as detected by imaging techniques. 2. Patients with history of other head and neck malignancies. 3. Patients with history of previous head and neck irradiation. 4. Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection. 5. Women who are pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control in the two arms | 33 months | Local control by RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The progression free survival in the two arms | 33 months | The time (in months) from the end of radiotherapy to the date of first progression |
| The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms | 33 months | The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0 |
Outcome results
None listed