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Phase III study of concurrent Chemoradiotherapy combined with Peg-Asp-IDE(PIDE) for localized Nasal Natural Killer/T-Cell Lymphoma: a prospective, two-arm, multi-center, randomized clinical study

Phase III study of concurrent Chemoradiotherapy combined with Peg-Asp-IDE(PIDE) for localized Nasal Natural Killer/T-Cell Lymphoma: a prospective, two-arm, multi-center, randomized clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17014083
Enrollment
Unknown
Registered
2017-12-21
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-29

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 chemotherapy
two:chemotherapy followed by concurrent chemoradiotherapy

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: 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: 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;complete response;partial response;Median survival time;

Countries

China

Contacts

Public ContactGang Wu

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

xhzlwg@163.com+86 13871240042

Outcome results

None listed

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