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

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

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.

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.

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