Phase II Study of Intensity-Modulated Proton Therapy for Recurrent Nasopharyngeal Carcinoma to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intensity-modulated proton radiotherapy for patients with recurrent nasopharyngeal carcinoma NPC that cannot be removed by surgery. This study aims to provide high-quality evidence to support proton therapy as a treatment option for recurrent NPC, addressing the limitations of current treatments like intensity-modulated radiotherapy IMRT, which may cause severe side effects and have limited survival rates. The study is a prospective clinical trial focusing on improving treatment outcomes and reducing complications for this patient group. Participants will receive proton therapy using a precise treatment plan designed to target tumors while sparing nearby healthy tissues. The prescribed radiation dose ranges from 60 to 66 Gray Gy, delivered in 30 to 33 sessions over 6 to 6.5 weeks, with treatments given five days per week. The therapy involves careful imaging and planning to define tumor areas and suspicious lesions, followed by treatment sessions using a Proton Therapy System ProBeam. During the study, participants will undergo evaluations of tumor control, survival, and potential side effects from enrollment through a three-year follow-up. Researchers will monitor severe late complications, overall survival time, and local progression-free survival time. Short-term treatment responses will also be assessed up to three months after treatment. This comprehensive monitoring will help determine the benefits and risks of proton therapy for recurrent NPC patients over an extended period.

Proton Therapy for Recurrent Nasopharyngeal Carcinoma