The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4
Radiotherapy: 50-56Gy
Shanghai Dong Fang hospital
Shanghai, Shanghai Municipality, China
Department of Hematology, Renji Hospital
Shanghai, Shanghai Municipality, China
South Renji hospital
Shanghai, Shanghai Municipality, China
Xin Jiang People's Hospital
Ürümqi, Xinjiang, China
Complete response rate
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time frame: 28 days after 4 cycles of chemotherapy
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time frame: 2-year
Overall Response rate
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time frame: 28 days after 4 cycles of chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time frame: Day 1 of each course and then every 3 months for 2 years
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time frame: 2-year
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Shanghai Ninth Peoples' Hospital
Shanghai, China
Shanghai Eye and ENT Hospital of Fudan University
Shanghai, China
Xinhua Hospital
Shanghai, China