GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma

Shanghai Jiao Tong University

Status: Completed

Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type

Treatments: Radiation: Radiotherapy; Drug: GELAD

Study type: Interventional

Funder types: Other

Identifiers

NCT02733458

XHLSG-NK-1601

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.

Full description

Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.

Enrollment: 52 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

GELAD/Radiation

Experimental group

Description:

Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.

Treatment:

Radiation: Radiotherapy

Drug: GELAD