Clinical Trial: Combine GELOX With Concurrent Radiation Therapy for Patients With Stage IE/IIE ENKTL

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

Official Title: Combination of Gemcitabine, Oxaliplatin, and Asparaginase (GELOX) With Concurrent Involved-Field Radiation Therapy for Patients With Stage IE/IIE Extranodal Natural Killer/T-Cell Lymphoma:a Phase II S

Brief Summary: 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.

Detailed Summary:

  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, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional). Epstein-Barr virus (E B V) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD 25) in the serum.
    • Recheck before and after every course: Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD25) in the serum.
    • Recheck every two course: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional)

  2. 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 cli
      Sponsor: Sun Yat-sen University

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

      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.



      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • progression free survival [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]
        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
      • 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 [ 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: March 2, 2014
      Date Started: March 2014
      Date Completion: March 2017
      Last Updated: April 18, 2016
      Last Verified: April 2016