NCT01667302

Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.

Detailed description

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Type	Name	Description
DRUG	Radiotherapy followed by chemotherapy	Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• Completion: 2016-12-01
• First posted: 2012-08-17
• Last updated: 2013-03-05

Locations

1 site across 1 country: China