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Phase II study of concurrent Chemoradiotherapy followed by Peg-Asp-GDP for localized Nasal Natural Killer/T-Cell Lymphoma: a prospective single-center clinical trial

Phase II study of concurrent Chemoradiotherapy followed by Peg-Asp-GDP for localized Nasal Natural Killer/T-Cell Lymphoma: a prospective single-center clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006263
Enrollment
Unknown
Registered
2015-04-17
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

Natural Killer/T-Cell Lymphoma

Interventions

one:Concurrent chemoradiotherapy followed by Peg-Asp-GDP chemotherapy

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria for study entry: 1. Aged 18 to 75 years old, ECOG performance status of 0, 1, or 2, Life expectancy of >12 weeks; 2. All patents are diagnosed as stage I/II Nasal Natural Killer/T-Cell Lymphoma by pathology and PET-CT/CT. All patients did not receive other treatment; 3. Adequate hematologic and hepatic-renal function: Hemoglobin >=9 g/dl, Absolute neutrophil count >=1.5*10^9/L, Platelet count >=100*10^9/L, ALT 1.5cm in its largest dimension on CT scan; 5. Adequate cardiopulmonary function, no other serious disease; 6. The Pregnancy test of blood or urine is negative for women of reproductive potential. All patients agree to use adequate methods of contraception during the treatment period and until >= 12 months after the last chemotherapy; 7. Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Patients received other treatment such as chemotherapy or radiotherapy; 2. Refuse to provide the blood sample; 3. History of severe allergic or anaphylactic reactions to any drugs including the protocol; 4. All patients of reproductive potential refuse to use adequate methods of contraception during the treatment period and until >12 months after the last chemotherapy; 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease, uncontrolled diabetes mellitus, pulmonary disease or severe hepatic and renal dysfunction; 6. Serious infections; 7. Contraindications of radiotherapy and chemotherapy; 8. History of other malignancy; 9. Mental disorder.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival;Overall survival;Response rate;

Secondary

MeasureTime frame
complete response;partial response;Median survival time;

Countries

China

Contacts

Public ContactGang Wu
xhzlwg@163.com+86 13871240042

Outcome results

None listed

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