Clinical Trial: Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
Brief Summary: The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.
Detailed Summary: Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.
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 ]
Original Secondary Outcome: Same as current
Information By: Fudan University
Dates:
Date Received: August 13, 2012
Date Started: June 2012
Date Completion: June 2017
Last Updated: March 2, 2013
Last Verified: March 2013
