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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Gemcitabine, Oxaliplatin and Pegaspargase and Etoposide, Vincristine, Doxorubicin, Cyclophosphamide and Prednisone as First-line Chemotherapy in Patients With NK/T-cell Lymphoma：a

Brief 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.

Detailed Summary:

ENKTL is an aggressive type of NHL characterized by poor survival, for which the optimal treatment strategies have not been fully defined. Radiation therapy (RT) is widely administered for patients with localized nasal disease, and produces a complete response (CR) rate of up to 70%.However, local and systemic failures are observed frequently in patients who receive RT alone.Therefore, chemotherapy is needed in combination with RT to reduce the risk of recurrence. Unfortunately, ENKTL shows a poor response to the CHOP chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine and prednisone) . EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide and prednisone) chemotherapy followed by involved field radiotherapy (IFRT) results in a CR rate of 75.0%. Recently, a chemotherapy regimen including gemcitabine,oxaliplatin and l-asparaginase (GELOX) has emerged, with promising results.Since 2003, a proportion of patients newly diagnosed with ENKTL were treated with the EPOCH chemotherapy regimen at some hospitals in China. From 2008, many hospitals in the southern part of China began to use the GELOX( Pegaspargase is used instead of l-asparaginase,P-Gemox).Our multicenter retrospective study showed the GELOX regimen produces a better long outcome with less toxicity than the EPOCH regimen for patients with early stage ENKTL.However,further prospective randomized clinical trials are needed to confirm the conclusion.

  1. Patients

    • All patients should sign a written informed consent form before enrollment, and the study should be approved by the Sun Yat-sen University Cancer Center Ethics Board.
    • Baseline of patients: Computed tomography (CT) scans of the chest, abdomen, and pelvis,
      Sponsor: Sun Yat-sen University

      Current Primary Outcome: progression free survival [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]

      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


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • complete remission rate [ Time Frame: every 4 weeks,up to completion of treatment(approximately 6 months) ]

        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.

      • overall survival [ Time Frame: .up to end of follow-up-phase (approximately 3 years) ]
        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
      • safety, as measured by adverse events [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]
        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)


      Original Secondary Outcome: Same as current

      Information By: Sun Yat-sen University

      Dates:
      Date Received: February 4, 2015
      Date Started: May 2015
      Date Completion: June 2018
      Last Updated: October 18, 2016
      Last Verified: October 2016