About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This study will include patients aged 18-70 years with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III) and no distant metastasis. Eligible participants must have completed two cycles of standard induction chemotherapy (e.g., TPF, GP, or TP), and the post-induction treatment evaluation must show stable disease (SD) or disease progression (PD) according to RECIST 1.1 criteria. Patients should have an ECOG Performance Status (PS) of 0-1 and adequate bone marrow, liver, and kidney function to tolerate concurrent chemoradiotherapy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Distant Metastasis-Free Survival
This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.
Complete Response Rate after Radiotherapy
This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.
Locations
Sponsors and contacts
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