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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT+GDP+Chidamide | Experimental | IMRT followed by GDP chemotherapy with chidamide during radiation and chemotherapy phase |
|
| RT+GDP | No Intervention | IMRT followed by GDP chemotherapy without chidamide during radiation and chemotherapy phase |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | chidamide administration during radiation and chemotherapy phase in the study group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Defined as the time from the date of study treatment until death from any cause | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Dong | Contact | 010-87787447 | dongmei030224@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mei Dong | Cancer Hospital, Chinese Academy of Medical Scienses | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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| 2 years |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |