This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.
Study Type
OBSERVATIONAL
Enrollment
223
Progression-Free Survival
The primary endpoint of this study is to compare the 3-year progression-free survival (PFS) rate between the two treatment groups. Disease progression will be assessed using RECIST 1.1 criteria, with imaging exams (such as MRI) used to monitor tumor size and progression.
Time frame: Baseline, 1 year, 2 years, 3 years
Local Regional Recurrence-Free Survival
This secondary endpoint will evaluate the 3-year local regional recurrence-free survival (LRRFS) rate between the two treatment groups.
Time frame: Baseline, 1 year, 2 years, 3 years
Overall Survival
This secondary endpoint will evaluate the 3-year overall survival (OS) rate. The OS rate will be compared between the re-induction chemotherapy followed by radiotherapy group and the direct radiotherapy group.
Time frame: Baseline, 1 year, 2 years, 3 years
Distant Metastasis-Free Survival
This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.
Time frame: Baseline, 1 year, 2 years, 3 years
Complete Response Rate after Radiotherapy
This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.
Time frame: 3 months post-treatment
3-4 Grade Acute Toxicity Incidence
This secondary endpoint will assess the incidence of grade 3 or 4 acute toxicity, based on the Common Terminology Criteria for Adverse Events (CTCAE) scale. The toxicity will be assessed during the course of the treatment.
Time frame: through study completion, an average of 4-6 months
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