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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extranodal NK/T-cell Lymphoma, Nasal Type

Intervention / Treatment
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* Drug: Radiotherapy followed by chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 14-70 years old Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract ECOG performance status 0-1 Life expectancy of more than 3 months Without prior history of pancreatitis Adequate bone marrow and organ functions Exclusion Criteria: Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level) Pregnant or lactating women With contraindication of steroid including uncontrolled diabetes Serious uncontrolled diseases and intercurrent infection History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy followed by chemotherapy<br>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 | Drug: Radiotherapy followed by chemotherapy<br>* 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<br>* Other names: DXM, IFO, VP-16, DDP, PEG-ASP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 3 years | 
| 3-year overall survival |  | 3 years | 
| Safety |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK/T-cell lymphoma, Radiotherapy, Adjuvant chemotherapy