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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.
Patients
Treatment Protocol - The GELOX regimen consist of the following drugs: gemcitabine :1250 mg/ m2 on days 1,ivdrip oxaliplatin :85 mg/m2 on day 1, ivdrip pegaspargase : 2500 IU/m 2 daily on day 1,intramuscular The treatment cycle was repeated every 14 days.
IFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions, we define the clinical target volume of limited stage IE disease as the bilateral nasal cavity, bilateral ethmoid sinuses, and ipsilateral maxillary sinus; and the clinical target volume would extend to involved tissues for patients who had extensive stage IE disease. For patients who had stage IIE disease, the clinical target volume also, included the bilateral cervical lymph node area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| concurrent chemoradiotherapy with GELOX | Experimental | 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 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. the first cycle of chemotherapy was initiated on the same day of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GELOX | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | 1.The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244. | every 4 weeks,up to completion of treatment(approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | progression free survival(PFS): time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first | up to end of follow-up-phase (approximately 3 years) |
| overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Epstein-Barr virus(EBV) DNA copies | Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) | |
| Plasma β2-microglobulin | every 3 weeks,up to completion of treatment(approximately 6 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZhongJun Xia, MD/PHD | Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China, | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| 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 |
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| ID | Term |
|---|---|
| C041775 | Gelox |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D001215 | Asparaginase |
| C042705 | pegaspargase |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| IFRT | Radiation | IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions |
|
overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first. |
| up to end of follow-up-phase (approximately 3 years) |
| safety | including hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | up to end of follow-up-phase (approximately 3 years) |
| serum sIL-2R level | every 3 weeks,up to completion of treatment(approximately 6 months) |
| D009369 |
| Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |