Combine GELOX With Concurrent Radiation Therapy for Patients With Stage IE/IIE ENKTL
NCT02080234 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2016-04-20
Summary
To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed stage IE/IIE ENKTL.
Conditions
- Lymphoma, Extranodal NK-T-Cell
Interventions
- DRUG
-
GELOX
gemcitabine :1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days
- RADIATION
-
IFRT
IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
ZhongJun Xia, MD/PHD · Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2016-12-31
- Completion
- 2017-03-31
Countries
- China
Study Locations
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