Status:
UNKNOWN
Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
- no prior radiotherapy or chemotherapy;
- age ≥ 18 years;
- ECOG performance status 0-2;
- Ann Arbor stages I and II;
- tumors primarily occurring in the upper aerodigestive tract;
- at least one unfavorable prognostic factor (age \> 60 years, B symptoms, elevated LDH, ECOG score 2, regional node involvement, and PTI);
- at least one measurable lesion;
- adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- life expectancy of more than 3 months.
Exclusion
- Patients with advanced stage disease;
- pregnancy or lactation;
- any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04511351
Start Date
August 1 2014
End Date
December 30 2020
Last Update
August 13 2020
Active Locations (1)
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1
National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses
Beijing, Beijing Municipality, China, 100021