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
In brief
Weekly cisplatin matches standard control and cuts severe toxicity by 16%
In a phase 3 trial of 272 patients with locally advanced head-and-neck cancer, weekly low-dose cisplatin produced a 2-year locoregional control rate of 61% versus 51% with the conventional three-weekly regimen, meeting the predefined non-inferiority margin. Grade 3-plus side effects fell from 61% to 45%, and hospitalisations were halved, suggesting a less toxic yet equally effective option.
- Journal
- Journal of the National Cancer Institute (Q1)
- Published
- 24 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Atul Sharma, Manish Kumar Choudhary, Suman Bhasker, Akash Kumar, Alok Thakar, Raja Pramanik, et al.
- PMID
- 42636269
- DOI
- 10.1093/jnci/djag276
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (top studies of the week, 30 August 2026): Weekly vs 3‑weekly cisplatin chemoradiation non‑inferiority trial
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.