Clinical trial NCT02631239: MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma
Official title: The Efficacy and Safety of Etoposide, Dexamethasone, Peg-asparaginase or Plus Methotrexate With Sandwiched Radiotherapy in the Treatment of Stage I to II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 256
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall response rate
timeFrame: 21 days after 4 cycles of chemotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: 2-year
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Day 1 of each course and then every 3 months for 2 years
measure: Progression free survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao, Prof
role: PRINCIPAL_INVESTIGATOR
References: