GELAD
DrugGemcitabine, 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
Other names: Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
NCT Number: NCT02733458
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.
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Notify Me15 year–75 year
All sexes
Interventional
Not applicable
Department of Hematology, Renji Hospital, Shanghai, Shanghai Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
Radiotherapy: 50-56Gy
Time frame: 28 days after 4 cycles of chemotherapy
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time frame: 2-year
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time frame: 28 days after 4 cycles of chemotherapy
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time frame: 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.
Time frame: 2-year
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Other
The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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