Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02733458
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated
* Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3
* Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.
* Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, serum creatinine\<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%
* No history of chemotherapy or radiotherapy.
* Signed Informed consented
Exclusion Criteria:
* Concurrent cancers need surgery or chemotherapy within 6 months.
* Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.
* Mental disorders.
* Pregnant or lactation
* HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
* History of pancreatitis
* Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
* Enrolled in other trial treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT02733458
Study Brief:
Protocol Section:
NCT02733458