Clinical Trial: GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma

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

Official Title: The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Mu

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.

Detailed Summary: Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: Progression free survival [ Time Frame: 2-year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 2-year ]
  • Response rate [ Time Frame: 28 days after 4 cycles of chemotherapy ]
  • Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Day 1 of each course and then every 3 months for 2 years ]


Original Secondary Outcome: Same as current

Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: April 5, 2016
Date Started: March 2016
Date Completion: December 2020
Last Updated: March 13, 2017
Last Verified: March 2017