Clinical Trial: Mild-dose IMRT for Early-staged Extranodal Nasal-type NK/T-cell Lymphoma With CR Tumor After GELOX Chemotherapy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Mild-dose Intensity-modulated Radiation Treatment for Stage IE/IIE Extranodal Nasal-type NK/T-cell Lymphoma With Complete Remission Tumor After Combination of Gemcitabine,

Brief Summary: This study is to make sure whether reduced-dose radiation treatment is sufficient to control the disease in patients with early-staged extranodal nasal-type NK/T-cell lymphoma, who have got complete remission tumor after chemotherapy in a new and more effective asparaginase-based GELOX regimen

Detailed Summary:

Definitive radiotherapy(RT) is mainstay in combined-modality treatment for patients with early-staged extranodal nasal-type NK/T-cell lymphoma(ENKTL),it can be used upfront or after short courses of chemotherapy. The typical dose of RT is recommended as 50-56Gy in conventional fractionations with 3 dimensional conformal RT or intensity-modulated radiation treatment(IMRT). Asparaginase-based chemotherapy regimens are being investigated, and primary results showed superior to previous anthracycline-based (eg. CHOP) chemotherapy. GELOX is a new asparaginase-based chemotherapy regimen designed and published in our institute, and the rate of complete remission(CR) is well improved. We hypothesis the reduced-dose radiation treatment(IMRT in 46Gy) is sufficient to control the disease in patients with early-staged ENKTL, who have got CR after GELOX chemotherapy, and to validate in this phase II study.

  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 (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA).
    • Recheck before and after GELOX chemotherapy and IMRT: Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, p
      Sponsor: Sun Yat-sen University

      Current Primary Outcome: loco-regional tumor control [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years. ]

      loco-regional tumor control was examined with physical examination and image methods.


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • progression-free survival(PFS) [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 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(OS) [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 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.


      Original Secondary Outcome: Same as current

      Information By: Sun Yat-sen University

      Dates:
      Date Received: August 27, 2014
      Date Started: October 2014
      Date Completion: October 2019
      Last Updated: September 28, 2014
      Last Verified: September 2014