Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage

• Status: Terminated
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with those of the EPOCH regimen for stage IE to IIE ENKTL.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Asparaginase; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Gemcitabine; Liposomal doxorubicin; Oxaliplatin; Pegaspargase; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• newly diagnosed ENKTL

• age:18-69years

• Ann Arbor stage IE,or stage IIE with cervical lymph node involvement

• 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)

Exclusion Criteria:

• mismatch the inclusion criteria

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

• primary lesion not from the upper respiratory