Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study to compare the efficacy of these two regimens. This prospective pilot study to compare the efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for stage IE to IIE ENKTL.
Treatment PA-Gemoxd dosages were as follows: days 1 and 5, 30-min intravenous infusion of 800 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2000 U/m2 PEG-ASP at four different sites; d1-5, intravenous infusion of 15mg dexamethasone. The regimen was repeated every 3 weeks for four cycles followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
P-Gemoxd Arm: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four. P-CHOP Arm: 2000U/m2 im on day 2 of each 21 day cycle. Number of Cycles: four.
800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.
85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four
15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.
750 mg/m2,ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
50mg/m 2,ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
1.4 mg/m 2(≤2mg),ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
60 mg/m 2 /day orally on days1- 5 of each 21 day cycle. Number of Cycles: four.
After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.
Hunan Cancer Hospital
Changsha, Hunan, China
Objective response rate(complete remission rate + partial remission rate)
The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.
Time frame: every 6 weeks,up to completion of treatment (approximately 6 months)
progression free survival
time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first
Time frame: up to end of follow-up-phase (approximately 3 years)
overall survival
overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first
Time frame: up to end of follow-up-phase (approximately 3 years)
Incidence of Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events v3.0
including hematological safety and non-hematological safety. All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: every 3 weeks,up to completion of treatment (approximately 6 months)
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