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Pegaspargase-based concurrent chemoradiotherapy in the treatment of stage I/II extranodal NK/T cell lymphoma: a single center, single arm, phase 2 clinical trial.

Pegaspargase-based concurrent chemoradiotherapy in the treatment of stage I/II extranodal NK/T cell lymphoma: a single center, single arm, phase 2 clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-15007662
Enrollment
Unknown
Registered
2015-12-28
Start date
1990-01-01
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 NK/T cell lymphoma

Interventions

treatment arm:combination of pegaspargase and concurrent radiotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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 who have not been treated by any antitumor approach; 4. Patient aged 18-75 years; 5. ECOG performance status 0-2; 6. 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

MeasureTime frame
two-year progression free survival (PFS) rate;

Secondary

MeasureTime frame
two-year overall survival rate;safety profile;complete response rate;

Countries

China

Contacts

Public ContactLu Yue
luyuesysucc@126.com+86 020 87342439

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026