MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
- Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
- Interventions
- Registration Number
- NCT02631239
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%\~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.
- Detailed Description
In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 256
- Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
- Age 14 ~ 70 years old
- ECOG(Eastern Cooperative Oncology Group）performance status 0~2
- Stage I to II
- Life expectancy>6 months
- Informed consented
- Chemotherapy before
- Bone marrow transplantation before
- History of malignancy
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- LVEF≤50%
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Lab at enrollment ALT or AST >3*ULN, AKP or bilirubin >2.5*ULN Creatinine>1.5*ULN
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- HIV infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MESA Radiotherapy Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy ESA Etoposide Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy ESA Pegaspargase Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy MESA Etoposide Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy ESA Radiotherapy Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy MESA Methotrexate Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy MESA Dexamethasone Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy MESA Pegaspargase Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy ESA Dexamethasone Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy
- Primary Outcome Measures
Name Time Method Overall response rate 21 days after 4 cycles of chemotherapy
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Day 1 of each course and then every 3 months for 2 years Overall survival 2-year Progression free survival 2-year
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China