This is an international multi-centre, non-inferiority phase III randomized controlled trial comparing concurrent chemoradiation with high dose cisplatin (Arm A) vs. hyperfractionated radiation therapy (Arm B) in patients with head and neck squamous cell carcinoma.
None
None
Parallel
70 gy 35 fractions/7weeks+high dose of cisplatin
Radiation70 Gy 35 fractions/7weeks+high dose of cisplatin
81.6 Gy /68 fractions BID FOR 7 WEEKS
Radiation81.6 Gy /68 fractions BID FOR 7 WEEKS
OVERALL SURVIVAL
To determine if hyperfractionated radiation therapy (Arm B) has a non-inferior overall survival (OS) compared to concurrent chemoradiation (CRT) with high dose cisplatin every 3 weeks (Arm A) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC).
Oncologic outcomes
To compare between arms the following: Oncologic outcomes: loco-regional failure (LRF)
Change in hearing threshold levels as assessed by pure tone audiometry
Hearing threshold levels will be measured using pure tone audiometry across standard audiometric frequencies. Changes from baseline hearing thresholds will be assessed and compared between study groups
Treatment-related toxicity/adverse events
Treatment-related toxicity/adverse events: physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v.5
Change from baseline in Head and Neck Cancer-specific quality of life as assessed by the University of Washington Quality of Life Questionnaire
Patient-reported quality of life and swallowing-related quality of life will be assessed using the University of Washington Quality of Life Questionnaire (UW-QOL) . Questionnaire with higher scores indicating better quality of life and swallowing function. Change from baseline scores will be evaluated at predefined study time points
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King Hussein Cancer Center
Lead sponsor
Princess Margaret Hospital, Canada
Collaborator