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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GELAD/Radiation | Experimental | Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GELAD | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | The complete response rate will be assessed on day 28 after the 4th course of chemotherapy. | 28 days after 4 cycles of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason. | 2-year |
| Overall Response rate | The complete response rate will be assessed on day 28 after the 4th course of chemotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, MD | Xinhua hospital, Shanghai Jiao Tong University of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dong Fang hospital | Shanghai | Shanghai Municipality | 200120 | China | ||
| Department of Hematology, Renji Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34806163 | Derived | Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21. |
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|
| Radiotherapy | Radiation | Radiotherapy: 50-56Gy |
|
| 28 days after 4 cycles of chemotherapy |
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0. | Day 1 of each course and then every 3 months for 2 years |
| Overall survival | Overall survival is defiend as the time from entry onto the treatment until death of any reason | 2-year |
| Shanghai |
| Shanghai Municipality |
| 201100 |
| China |
| South Renji hospital | Shanghai | Shanghai Municipality | 201100 | China |
| Xin Jiang People's Hospital | Ürümqi | Xinjiang | 830001 | China |
| Shanghai Ninth Peoples' Hospital | Shanghai | 200011 | China |
| Shanghai Eye and ENT Hospital of Fudan University | Shanghai | 200031 | China |
| Xinhua Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D005047 | Etoposide |
| D003907 | Dexamethasone |
| C042705 | pegaspargase |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D013812 | Therapeutics |
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