Radomized and Controlled Phase II Study and Prognosis Analysis for the Early Stage and High Risk Extranodal Nasal NK/T Cell Lymphoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-15007350

Enrollment

Unknown

Registered

2015-10-28

Start date

2015-06-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal nasal NK/T cell lymphoma

Interventions

Experimental :Chidamide+radiotherapy+chemotherapy

Control :radiotherapy+chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histology and immunohistochemical confirm primary upper respiratory (include nasal cavity, nasopharynx, oropharynx, oral cavity and larynx) NK/T cell lymphoma; 2. Stage IE and IIE; 3. Patients with any one of the unfavourable prognosis factors: age > 60 years; Increased LDH; Stage II; Neighboring organs or multi regions have been invaded by the primary tumor, or the skin and sclerotin are involved; ECOG performance status >=2; with B symptoms; 4. Patients who have not been treated by any antitumor approach; 5. Patient aged 18-75 years; 6. ECOG performance status 0-2; 7. Have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Women in pregnancy or lactation, or patients in child-bearing period who would not conduct birth control; 2. Patients have been diagnosed to have other malignant tumors (except skin basal cell carcinoma and cervical carcinoma in situ) in five years; 3. Organ transplant patients; 4. Patients who have participated other drug clinical trials in 30 days; 5. Patients had main organ surgery 1.5*upper limit of normal; Transaminases (ALT or AST) >2.5*upper limit of normal]. Abnormal renal function (serum creatinine > 1.5*upper limit of normal); Absolute neutrophil count < 1.5*10^9/L, platelet count <80*10^9/L, hemoglobin <90 g/L; 9. Patients with mental disorder or patients could not provide inform consent; 10. Drug and alcohol abuse that would affect the evaluation for the test results; 11. Any other condition which is inappropriate for the study in the opinion of the investigators.

Design outcomes

Primary

Measure	Time frame
Progression free survival rate at 2 years;	—

Secondary

Measure	Time frame
Overall survival rate at 2 years;Objective response rate;Local control rate at 2 years;Toxicities;	—

Countries

China

Contacts

Public ContactMei Dong, Yexiong Li

13811929322@163.com+86 13811929322

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026