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

Locally Advanced Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03699969
• Other study ID #: HN12016
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 15, 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: October 15, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Head and Neck Cancer

Intervention

Radiation:
• Hypofractionated dose escalated VMAT
measure the local control, progression free survival and overall survival

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control in the two arms	Local control by RECIST criteria	33 months
Secondary	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
Secondary	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