Nasopharyngeal Neoplasms Clinical Trial
Official title:
Phase 2 Study of Inductive Plus Concurrent Chemoradiation Versus Concurrent Plus Adjuvant Chemoradiation for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
The purpose of this study is to determine whether Intensity-modulated radiation therapy (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin and paclitaxel) is feasible and effective than current standard treatment for high-risk locally advanced NPC patients.
Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally
advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond
all concurrent chemotherapy with cisplatin benefits most. However, from Lin's (Lin JC, 2004)
study, locally advanced NPC with high risk factors can not benefit from conventional
concurrent chemoradiation. Failure pattern analysis revealed that local and distant failure
accounted for 50% respectively. Large-scale data has demonstrated that with IMRT, local
control can achieve 90%. Previous studies showed inductive chemotherapy can decrease distant
metastasis. We need more effective and stronger chemotherapy, and we still need to testify
concurrent chemotherapy combined with inductive chemotherapy.
A prospective trial would thus provide valuable information to help physicians and patients
more precisely identify the feasibility and effectiveness of inductive + concurrent
chemotherapy combined with IMRT for high-risk locally advanced NPC.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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