Currently, combined chemotherapy (CT) and radiation (RT) is recognized as the standard treatment for high-risk early-stage NKTCL. However, treatment failure occured in nearly 30% of patients receiving CRT and systemic failure are the most common failure form. Chidamide is a HADC inhibitor, which presents satisfactory efficacy in NKTCL especially in terms of improving durable remission time. In our previous study, IMRT followed by GDP was demonstrated effective in early-stage NKTCL. Therefore, we designed a prospective phase II clinical trial of IMRT followed by GDP with or without chidamide in patients with high-risk early-stage NKTCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
chidamide administration during radiation and chemotherapy phase in the study group
National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival
Defined as the time from the date of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Time frame: 2 years
Overall Survival
Defined as the time from the date of study treatment until death from any cause
Time frame: 2 years
Treatment response
Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014)
Time frame: 2 years
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