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A prospective phase III multicenter randomized clinical study of radiotherapy dose selection for patients with early stage extranodal nasal NK/T cell lymphoma after complete response of chemotherapy

A prospective phase III multicenter randomized clinical study of radiotherapy dose selection for patients with early stage extranodal nasal NK/T cell lymphoma after complete response of chemotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043614
Enrollment
Unknown
Registered
2021-02-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

extralnodal nature killer/T-cell lymphoma, nasal type

Interventions

Group A:50Gy radiotherapy
Group B:45Gy radiotherapy

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old; 2. Patients with extranodal nasal type NK/T cell lymphoma confirmed by histopathology (recommendation for consultation with the center for difficult pathology); 3. Ann Arbor stage I and II nasal patients; 4. After first-line chemotherapy before enrollment, the efficacy evaluation of imaging evaluation reached CR; 5. Have regular organ functions: blood routine, normal liver and kidney function (WBC >= 3.5 x 10^9/L, ANC >= 1.5 x 10^9/L, HGB > 100 g/L, PLT > 90 x 10^ 12/L, ALT, AST < 2.5ULN) 6. No other anti-tumor treatments (including anti-tumor Chinese medicines, proprietary Chinese medicines and steroid drugs); 7. Able to understand and voluntarily participate in this trial, and be able to sign informed consent; 8. Female patients of childbearing age have a negative urine pregnancy test before treatment, and all enrolled patients must agree to avoid pregnancy or cause pregnancy during the study period and within 6 months after stopping treatment 9. ECOG behavior performance status <= 2; 10. Life expectancy is greater than or equal to 3 months.

Exclusion criteria

Exclusion criteria: 1. Other types of lymphoma; 2. Ann Arbor stage III-IV; 3. Combined with any other malignant tumor history; 4. There are active infections that require treatment with systemic antibiotics or antiviral drugs and cannot receive the treatment specified in this research protocol; 5. Decompensated heart failure, dilated cardiomyopathy, coronary heart disease showing ST-segment depression on the electrocardiogram and myocardial infarction that occurred within the last 6 months; 6. Patients with severe infections or organic diseases; 7. Renal insufficiency not related to lymphoma (serum creatinine concentration exceeds 2 times the upper limit of normal); 8. Liver insufficiency not related to lymphoma (transaminase exceeding 3 times the upper limit of normal and/or blood bilirubin greater than 2.0 mg/dl); 9. There are clinical symptoms of brain dysfunction, serious mental illness; 10. Women during lactation or pregnancy.

Design outcomes

Primary

MeasureTime frame
disease-free survival, DFS;overall survival, OS;

Countries

China

Contacts

Public ContactHuangming Hong

Sichuan Cancer Hospital

honghm3@mail.sysu.edu.cn+86 28-85420816

Outcome results

None listed

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