Clinical Trial: Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
Brief Summary: The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
Detailed Summary: For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.
Sponsor: Fudan University
Current Primary Outcome: 3-year Progression-free survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall response rate [ Time Frame: 3 years ]
- 3-year overall survival [ Time Frame: 3 years ]
- Safety [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Fudan University
Dates:
Date Received: August 13, 2012
Date Started: June 2012
Date Completion: December 2016
Last Updated: March 2, 2013
Last Verified: March 2013
