Phase II Study of 18F-FDG PETCT Guided Reduced-dose Radiotherapy in Adults with Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating whether using 18F-FDG PETCT scans to guide reduced-dose radiotherapy can maintain survival outcomes in patients with nasopharyngeal carcinoma NPC. This phase II study focuses on patients with NPC stages I to IVA and investigates the effectiveness of adjusting radiation doses based on metabolic responses during treatment. Patients receive intensity modulated radiation therapy IMRT with two possible dosing plans depending on their metabolic response at the 25th radiation fraction. Those achieving complete metabolic response CMR or over 70% partial metabolic response PMR receive a reduced dose of 63.6 Gy delivered in 30 fractions, while others receive the conventional dose of 70 Gy in 33 fractions. Chemotherapy is also administered based on disease stage, with stage II patients receiving concurrent cisplatin during IMRT, and stage III-IVA patients receiving platinum-based induction chemotherapy followed by cisplatin concurrent with IMRT. Participants undergo regular imaging with 18F-FDG PETCT to measure metabolic response, alongside clinical assessments of survival and complications. The primary outcome is local-regional recurrence-free survival at 5 years, with secondary outcomes including overall survival, progression-free survival, distant metastasis-free survival, treatment-related complications, and overall response rate measured over up to 5 years. The study duration and follow-up are designed to evaluate both short-term and long-term effects of the radiotherapy dosing strategies.

18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma