A Phase 2 interventional study of GELOX and IFRT in Lymphoma, Extranodal NK-T-Cell, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
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.
Drug: GELOX · Radiation: IFRT
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
Also known as: gemcitabine, oxaliplatin, asparaginase, pegaspargase
IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions
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.
Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)
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
Time frame: up to end of follow-up-phase (approximately 3 years)
overall survival
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.
Time frame: 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)
Time frame: up to end of follow-up-phase (approximately 3 years)
Epstein-Barr virus(EBV) DNA copies
Time frame: Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months)
Plasma β2-microglobulin
Time frame: every 3 weeks,up to completion of treatment(approximately 6 months)
serum sIL-2R level
Time frame: every 3 weeks,up to completion of treatment(approximately 6 months)
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University