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

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.

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.

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