Extranodal NK-T-Cell Lymphoma, Nasal Type
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGELAD
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
RADIATIONRadiotherapy
Radiotherapy: 50-56Gy
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated * Eastern Cooperative Oncology Group (ECOG ) performance status 0\ 3 * Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity. * Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, serum creatinine\<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50% * No history of chemotherapy or radiotherapy. * Signed Informed consented
Exclusion criteria
* Concurrent cancers need surgery or chemotherapy within 6 months. * Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis. * Mental disorders. * Pregnant or lactation * HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml. * History of pancreatitis * Known history for grade 3/4 allergy to the drugs in chemotherapy regimen. * Enrolled in other trial treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 28 days after 4 cycles of chemotherapy | The complete response rate will be assessed on day 28 after the 4th course of chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2-year | Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason. |
| Overall Response rate | 28 days after 4 cycles of chemotherapy | The complete response rate will be assessed on day 28 after the 4th course of chemotherapy. |
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Day 1 of each course and then every 3 months for 2 years | Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0. |
| Overall survival | 2-year | Overall survival is defiend as the time from entry onto the treatment until death of any reason |
Countries
China
Outcome results
None listed