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Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL — ENKTL  

Extranodal NK/T-cell Lymphoma Clinical Trial

Official title:
Evaluate the Safety and Efficacy of Pegaspargase-based Concurrent Chemoradiotherapy in the Treatment of Early Stage Extranodal NK/T Cell Lymphoma

Clinical Trial Summary

The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of concurrent chemoradiotherapy by using single-drug pegaspargase for patients with ENKTL in stage IE to IIE.

Clinical Trial Description

The treatment regimen included CCRT ( involved field radiotherapy 50GY, concurrent 2 cycles of pegaspargase treatment ) followed by 4 cycles of pegaspargase. Chemotherapy and RT were performed simultaneously within one week after enrollment. The administration regimen was as follows : day1, deep intramuscular injection of 2500 unit/m2 pegaspargase at three different sites, and repeated once every 3 weeks. 3D conformal radiotherapy was performed using 4 or 6 MV photons generated by a linear accelerator. The radiation dose was 50 Gy, 2.0 Gy / time, 1 time / d, for 5 weeks. The clinical target volume ( CTV ) of limited stage IE patients was defined as bilateral nasal cavity, bilateral ethmoid sinus and ipsilateral maxillary sinus. The CTV of extensive stage IE patients was extended to the affected tissues. The CTV of stage IIE lesions also included the involved cervical lymph node area. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06406556
Study type Interventional
Source Sun Yat-sen University
Contact Hua Wang, MD
Phone 15920352412
Email wanghua@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date March 1, 2016
Completion date March 1, 2026
View Details
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