Phase 3 Trial Comparing Surgery Alone to Chemotherapy Followed by Surgery for Oral Cavity Squamous Cell Cancer with Advanced Lymph Node Involvement

What this Trial Is About

Researchers are studying oral squamous cell carcinoma, focusing on patients with advanced nodal disease N2-N3 who are operable and present biologically aggressive tumors. The study aims to evaluate whether adding induction chemotherapy before surgery improves 2-year disease-free survival compared to upfront surgery alone. This phase 3, open-label, multi-center randomized controlled trial addresses previous trial limitations by selecting a more homogenous patient group likely to benefit from chemotherapy. Secondary goals include assessing overall survival, treatment response, compliance, toxicity, postoperative complications, quality of life, and tumor biobanking for future research. The study compares two treatment approaches. The standard arm involves surgery wide local excision with comprehensive neck dissection followed by adjuvant radiotherapy with or without concurrent chemotherapy. The experimental arm adds two cycles of induction chemotherapy using TPF or TPX regimens before surgery and similar adjuvant treatment. Patients will receive standard care according to current guidelines, with surgery timed after assessing chemotherapy response. Participants aged 18 to 75 with confirmed operable oral squamous cell carcinoma and advanced nodal involvement will be followed for up to five years. Researchers will monitor disease-free survival at two years as the primary outcome, alongside overall survival, treatment completion, toxicity, quality of life assessments over multiple timepoints, and surgical morbidity. Tumor and blood samples will be collected for biobanking. Safety and quality of life will be tracked regularly, including early and late radiotherapy-related toxicities and financial impact questionnaires.

Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers: