Nasal and Nasal-type NK/T-cell Lymphoma
Conditions
Keywords
NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS
Brief summary
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage I/II Natural Killer (NK)/T Cell Lymphoma.
Detailed description
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage I/II NK/T cell lymphoma.
Interventions
DDP 20 mg/m2,ivgtt（intravenously guttae）, d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
OTHERVIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）
DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
OTHERgemcitabine,pegaspargase,cisplatin,dexamethasone
Radiotherapy 50Gy is followed by chemotherapy(DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
OTHERcisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna
Radiotherapy 50Gy is followed by chemotherapy(DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
RADIATIONRadiotherapy
Suitable type intensity-modulated radiation therapy(IMRT)50Gy
Sponsors
Second Hospital of Shanxi Medical University
Shanxi Province Cancer Hospital
Wuhan University
Wuhan TongJi Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Qingdao University
Cancer Hospital of Guizhou Province
Xinyang Central Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Mingzhi Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months * Histological confirmed NK/T cell lymphoma * None of chemotherapy or radiotherapy has been previously used * None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) * At least one measurable lesion * None of other serious diseases, cardiopulmonary function is normal * Pregnancy test of women at reproductive age must be negative * Patients could be followed up * None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent.
Exclusion criteria
* Disagreement on blood sample collection * Patients allergic of any of drug in this regimen or with metabolic disorder * Pregnant or lactating women * Serious medical illness likely to interfere with participation * Serious infection * Primitive or secondary tumors of central nervous system * Chemotherapy or radiotherapy contraindication * The evidence of CNS metastasis * History of peripheral nervous disorder or dysphrenia * patients participating in other clinical trials * patients taking other antitumor drugs * patients estimated to be unsuitable by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | up to end of follow-up-phase (approximately 24 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | every 6 weeks,up to completion of treatment(approximately 18 weeks ) | 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles. |
| overall survival | up to the date of death (approximately 5 years) | — |
| median survival time | 5 years | — |
Countries
China
Contacts
Primary ContactMingzhi Zhang, Pro，Dr
Outcome results
None listed