Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Treatments: Drug: Radiotherapy followed by chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01667302

LMTG 12-02

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.

Full description

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range 14-70 years old
• Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
• ECOG performance status 0-1
• Life expectancy of more than 3 months
• Without prior history of pancreatitis
• Adequate bone marrow and organ functions

Exclusion criteria

• Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
• Pregnant or lactating women
• With contraindication of steroid including uncontrolled diabetes
• Serious uncontrolled diseases and intercurrent infection
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Radiotherapy followed by chemotherapy

Experimental group

Description:

Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1

Treatment:

Drug: Radiotherapy followed by chemotherapy