Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.

Detailed Description
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Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.

Official Title
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A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma

Conditions
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Extranodal NK/T-cell Lymphoma, Nasal Type

Intervention / Treatment
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* Radiation: Radiotherapy alone
* Drug: Concurrent chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18-75 years old Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level ECOG performance status 0-1 Life expectancy of more than 3 months Adequate bone marrow and organ functions Exclusion Criteria: non-nasal NK/T-cell lymphoma Prior exposure of methotrexate With third space effusion Pregnant or lactating women 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: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy alone<br>Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy | Radiation: Radiotherapy alone<br>* Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy<br>|
| Experimental: Concurrent chemoradiation<br>Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy | Radiation: Radiotherapy alone<br>* Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy<br>Drug: Concurrent chemoradiation<br>* Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy<br>* Other names: MTX;|

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK/T-cell lymphoma, Methotrexate, Radiotherapy, Concurrent chemoradiation