NCT01797900

The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nasopharyngeal Neoplasms

Interventions

Type	Name	Description
DRUG	Cisplatin	induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64
DRUG	Paclitaxel	induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64
RADIATION	IMRT	69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-02-25
• Last updated: 2014-09-10

Locations

1 site across 1 country: China