Treatment of Natural Killer/T Cell Lymphoma-I/II

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.

Conditions

• Nasal and Nasal-type NK/T-cell Lymphoma

Interventions

OTHER

DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)

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.

OTHER

VIPD（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.

OTHER

gemcitabine,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.

OTHER

cisplatin,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.

RADIATION

Radiotherapy

Suitable type intensity-modulated radiation therapy(IMRT)50Gy

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Qingdao University

  collaborator OTHER

• Cancer Hospital of Guizhou Province

  collaborator OTHER

• Xinyang Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• Mingzhi Zhang

  lead OTHER

Principal Investigators

• Mingzhi Zhang, Pro,Dr · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2015-12-31

Completion

2019-05-31

Countries

• China

Study Locations