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

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

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

Study Overview

• Status: Unknown
• Conditions: Locally Advanced Head and Neck Cancer
• Intervention / Treatment: Radiation: Hypofractionated dose escalated VMAT

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Anticipated): October 15, 2018

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: head and neck cancer; VMAT; Hypofractionation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HN12016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No