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

NCT02359162 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

  • Lymphoma, Extranodal NK-T-Cell

Interventions

DRUG

Gemcitabine

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

DRUG

Oxaliplatin

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

DRUG

Pegaspargase

pegaspargase : 2500 IU/m2 (intramuscular injection)

DRUG

Etoposide

50 mg/m 2 /day 24 h continuous infusion on days 1-4

DRUG

Vincristine

0.4 mg/m 2 /day 24 h continuous infusion on days 1-4

DRUG

Doxorubicin

10 mg/m 2 /day 24 h continuous infusion on days 1-4

DRUG

Cyclophosphamide

cyclophosphamide 750 mg/m2 /day over 15 min intravenously on day 5

DRUG

Prednisone

60 mg/m 2 /day 60 mg/m 2 /day on days 1-5

RADIATION

IMRT

IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 grays (Gy) in 25 fractions.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hua Wang, MD. · Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359162 on ClinicalTrials.gov