An open-label, noninferiority phase III RCT of weekly versus three weekly cisplatin and radical radiotherapy in locally advanced head and neck squamous cell carcinoma (ConCERT trial).

• DOI: 10.1200/jco.2022.40.16_suppl.6004
• Publication Date: 2024-10-03T19:47:12Z
• Authors: Atul Sharma; Manish Kumar; Suman Bhasker; Alok Thakar; Raja Pramanik; Ahitagni Biswas; akash kumar; Kapil Sikka; Amit Chirom Singh; Supriya Mallick; Rajeev Kumar; S.V.S. Deo; Aanchal Kakkar; Saphalta Baghmar; Amit Sehrawat; Pooja Sethi; Ashok Kumar; Sandeep Seth; Ashish Dutt Upadhyay; Sanjay Thulkar
• Keywords: Open label

6004 Background: CCRT using 3 weekly cisplatin (DDP) 100mg/m 2 is considered standard nonsurgical option for LAHNSCC. Many prefer DDP 40 mg/m assuming this to be non inferior, with better radio sensitization, and less toxic but without robust supporting evidence. We designed inferiority trial compare DDP. Methods: Multicentric RCT 100 (Control as C) x times (Test T) x7 concurrent RT definitive therapy in nasopharyngeal Primary objective was years loco regional control (LRC) rates. Secondary endpoints included OS, PFS, toxicity, compliance, others. Assuming LRC of 60%, power 80%, alpha error 5%, margin 10% 143 patients each arm were required (including evaluable etc). Results: Between April 2018 January 2021, 278 randomised. Median age 56 (range 19-70), 89.6% males. sites were, oropharynx (59.6%), larynx (17.5%), hypopharynx, oral cavity (11.6%) each. TNM stage was, III (29.1%), IVA (50.5%), IVB (20.4%). 13% oropharyngeal who tested p16 found positive. ECOG PS 0-1 78.9%. 135 eligible treatment 132 received some form treatment. Baseline characteristics (Chi square/Fisher’s exact test) well balanced except higher number LVEF <50% T (p=0.035). 87.2% C arm, 81.6% ≥ 60 Grays (p=.94), 78.6% 200 mg/m2 (p=.31). There more delays (p=NS). Treatments interruptions (p=0.035), hospitalizations (p=0.004), use additional IV fluids (p= <.001), mucositis (p=.029), myelosuppression (P=.021), renal toxicity (p=<.001), vomiting ((p=.002), hyponatremia (p=.004) all significantly arm. 10 deaths 7 85.4% achieved CR+PR (p=.055). rates at 57.69% 61.53% an absolute difference 3.84% (one sided 95% CI= -6.15, 13.80) which within the pre defined -10%. Cumulative year 52.6% 47.4% (log-rank p=0.426; HR 0.86 [95%CI: 0.60-1.23]) by parametric survival estimates 5.2% (95%CI= -7.7, 18.2) again margin. no significant median time loco-regional failure (C=21.23 months T= NR; p=.45), OS (C=30.50 25.46; p=.59) PFS (C=20.60 20.66; p=.46). Conclusions: This academic confirms that inferior DDP, tolerated interruptions, hospitalizations, should now one standards. Clinical information: CTRI/2018/03/012422.