Phase II Study of Cyclin D1 Guided TPF Induction Chemotherapy Followed by Surgery and Radiotherapy for Oral Squamous Cell Carcinoma Patients with cN2 Stage

What this Trial Is About

Researchers are evaluating the predictive value of the protein Cyclin D1 for guiding TPF induction chemotherapy in patients with clinical N2 stage oral squamous cell carcinoma OSCC. This phase II randomized controlled trial aims to determine if patients with high Cyclin D1 expression benefit from TPF induction chemotherapy compared to surgery and radiotherapy alone. The study addresses ongoing debates about the clinical value of induction chemotherapy in advanced, resectable OSCC and builds on prior research showing subgroup benefits in similar patients. Participants are randomly assigned to one of two groups the experimental group receives two cycles of TPF induction chemotherapy docetaxel, cisplatin, and 5-fluorouracil followed by radical surgery and post-operative radiotherapy, while the control group undergoes surgery and post-operative radiotherapy alone. Chemotherapy is administered intravenously every three weeks with supportive care measures to manage side effects. Surgery involves radical resection and neck dissection with reconstruction, followed by radiotherapy starting 4 to 6 weeks after surgery. Radiotherapy is delivered five days a week for six weeks at specified doses, with additional chemotherapy recommended for high-risk features. Participants undergo baseline tumor assessment and clinical evaluations before surgery, with tumor response measured by clinical and imaging criteria. Toxic effects are monitored weekly during chemotherapy and radiotherapy. Follow-up includes regular monitoring every three months for two years, then every six months for two more years, and annually thereafter. The primary outcome is overall survival at two years, with secondary outcomes including disease-free survival, local recurrence-free survival, and distant metastasis-free survival. The total participation duration covers recruitment, treatment, and follow-up periods with ongoing safety and efficacy assessments.

Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage