Concurrent chemotherapy and external radiation therapy (ConCERT): phase 3 noninferiority randomized clinical trial of cisplatin weekly vs every 3 weeks in locally advanced squamous cell carcinoma of the head and neck

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2026
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Abstract
Abstract Introduction Concurrent chemoradiotherapy with cisplatin (100 mg/m² every three weeks) is the standard for locally advanced head and neck squamous cell carcinoma (LA-HNSCC), but it is uncertain if weekly cisplatin (40 mg/m²) is non-inferior. Method This open-label, multicentre, phase III non-inferiority trial randomised patients with non-nasopharyngeal LA-HNSCC in a ratio of 1 1 to receive either the standard cisplatin regimen (100 mg/m² every three weeks) or the experimental weekly regimen (40 mg/m²), both with 70 Gy concurrent radiation. The primary endpoint was 2-year locoregional control (LRC) and non-inferiority margin was kept as 10% (-10%). Results From April 2018–January 2021, 278 patients were enrolled (137 standard and 141 experimental arm); 272 were eligible for final analysis. Median follow-up was 43.9 months. Two-year LRC rates were 61.3% (experimental arm) and 51.1% (standard arm) with an absolute difference of 10.2% (one-sided 95% CI 0.3), within the non-inferiority margin. Hazard ratio was 0.72 (95% CI: 0.50 to 1.05, P = 0.091). Kaplan-Meier analysis also confirmed non-inferiority (absolute difference 10.8%). Median progression-free survival was 17.9 months (standard) and 20.3 months (experimental) (P = 0.204); median overall survival was 22.2 months (standard) and 24.9 months (experimental) (P = 0.501). Grade 3 or higher adverse events occurred more in the standard arm (60.7% vs 44.7%, P = 0.018), as did hospitalisations (36.8% vs 20.3%, P = 0.004). Conclusion Weekly low-dose cisplatin-based chemoradiation is non-inferior to 3-weekly high-dose cisplatin and is associated with lower toxicity and fewer hospitalisations, making it a viable treatment option for non-nasopharyngeal LA-HNSCC.
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Authors Atul Sharma, Manish Kumar Choudhary, Suman Bhasker, Akash Kumar, Alok Thakar, Raja Pramanik, Ahitagni Biswas, Kapil Sikka, Surya V S Deo, Ashok Kumar, Supriya Mallick, Amit Chirom Singh, Pooja Sethi, Amit Sehrawat, Vishnubhatla Sreenivas, Rajeev Kumar, Saphalata Baghmar, Aanchal Kakkar, Vinod Sharma, Babita Kataria, Ranjit Sahoo, Aman Sharma, Prasanth Ganesan, Sudhir Kumar, Amol Patel, Smriti Panda, Sanjay Thulkar, Sandeep Seth, Shikha Halder, Manoj Gupta, Ashish Dutt Upadhyay
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Journal JNCI Journal of the National Cancer Institute
Year 2026
DOI
10.1093/jnci/djag276
URL
https://doi.org/10.1093/jnci/djag276
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