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

Not Applicable

• Conditions: Locally Advanced Head and Neck Cancer
• Interventions: Radiation: Hypofractionated dose escalated VMAT

• Registration Number: NCT03699969
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-10
• Primary Completion: 2018-10-01
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11
• Study Completion: 2018-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated dose escalated VMAT	Hypofractionated dose escalated VMAT	Hypofractionated dose escalated VMAT radiotherapy

Primary Outcome Measures

Name	Time	Method
Local control in the two arms	33 months	Local control by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
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