Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma
NCT04511351 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2020-08-13
Summary
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.
Conditions
Interventions
- DRUG
-
Chidamide
chidamide administration during radiation and chemotherapy phase in the study group
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Mei Dong · Cancer Hospital, Chinese Academy of Medical Scienses
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-01
- Primary Completion
- 2020-12-30
- Completion
- 2020-12-30
Countries
- China
Study Locations
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