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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Extranodal NK-T-Cell Lymphoma, Nasal Type

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GELAD/Radiation

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.

Group Type EXPERIMENTAL

GELAD

Intervention Type DRUG

Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4

Radiotherapy

Intervention Type RADIATION

Radiotherapy: 50-56Gy

Interventions

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GELAD

Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4

Intervention Type DRUG

Radiotherapy

Radiotherapy: 50-56Gy

Intervention Type RADIATION

Other Intervention Names

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Gemcitabine, Etoposide, Dexamethasone, Pegaspargase

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No