Adverse Event Profile and Compliance of Docetaxel with Radiation in Cisplatin-Ineligible Patients of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Research Protocol

Introduction: Concomitant chemoradiation with cisplatin is standard treatment for non-metastatic head and neck cancers, but often limited by toxicities, especially deranged renal function and hearing complications. This leads to limited cycles of cisplatin due to challenges in administration and is not suitable for patients with poor renal function and hearing issues. Need of the study: Not enough data is available for patients who are not suitable for cisplatin administration along with radiation either due to sensitivity to cisplatin or the adverse effects mentioned earlier. Docetaxel has been recently observed to benefit such patients in overall response outcome including Disease Free Survival (DFS) and Overall Survival (OS) when administered concurrently with radiation. Improved clinical response with minimal toxicity to normal tissue is seen with docetaxel, as it is a phase-specific agent. Therefore, this would be a good alternative to Cisplatin in patients with deranged kidney function and sensorineural hearing loss. Aim: To estimate the adverse event profile and compliance of docetaxel with radiation. Methodology: This prospective observational study will be conducted in the department of Medical Oncology and Radiation Oncology at Sidharth Gupta Memorial Cancer Hospital, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha, Maharashtra, India, starting from May 2024 to May 2025. Patients with pathologically confirmed non-metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), who are planned for Concurrent Chemoradiation (CCRT) but not suitable for cisplatin, will receive concurrent weekly docetaxel at a dose of 15 mg/sqm. Radiotherapy (RT) will be delivered according to the institutional protocol, daily dose of 200 cGy for five days a week will be given. Continuous monitoring during treatment will include weekly clinical evaluations, regular blood tests (haemoglobin, blood counts, renal functions), and grading of adverse events (CTCAE v5 criteria). Treatment response will be assessed via clinical evaluation and CECT scans (RECIST v1.1). Statistical analysis will be performed using Statistical Package for Social Sciences (SPSS) version 26.0 and will involve analysis of categorical variables with Chi-square and Fisher-exact tests, and continuous variables with unpaired t-tests and Analysis of Variance (ANOVA). Time to event analysis will be done using the Kaplan-Meier method with p-value <0.05 considered significant.