P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

NCT ID: NCT02533323

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-01-31

Brief Summary

This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Detailed Description

Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. Stage IIIE/IVE patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

Conditions

Lymphoma, Extranodal NK-T-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

P-Gemox

P-Gemox: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.

Group Type: EXPERIMENTAL

gemcitabine

Intervention Type: DRUG

gemcitabine :1250mg/m2 (ivdrip) on days 1

oxaliplatin

Intervention Type: DRUG

oxaliplatin :85 mg/m2 (ivdrip) on day 1

pegaspargase

Intervention Type: DRUG

pegaspargase : 2500 IU/m2 (intramuscular injection)

Interventions

gemcitabine

gemcitabine :1250mg/m2 (ivdrip) on days 1

Intervention Type: DRUG

oxaliplatin

oxaliplatin :85 mg/m2 (ivdrip) on day 1

Intervention Type: DRUG

pegaspargase

pegaspargase : 2500 IU/m2 (intramuscular injection)

Intervention Type: DRUG

Other Intervention Names

Gemzar; Eloxatin; Oncaspar

Eligibility Criteria

Inclusion Criteria

• newly diagnosed ENKTL
• age:18-80years
• at lease one measurable lesion
• receive no chemotherapy or radiotherapy before
• Eastern CooperativeOncology Group performance status of 0 to 2.
• Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

• systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

dr. luyue

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yue lu, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Hematological Oncology, Sun Yat-sen University Cancer Center

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-NK/T-5010

Identifier Type: -

Identifier Source: org_study_id