Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma

Phase 2TerminatedNCT01667289

Fudan University4 enrolled

Overview

The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.

Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Radiotherapy aloneRADIATION

Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy

Concurrent chemoradiationDRUG

Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age range 18-75 years old * Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level * ECOG performance status 0-1 * Life expectancy of more than 3 months * Adequate bone marrow and organ functions Exclusion Criteria: * non-nasal NK/T-cell lymphoma * Prior exposure of methotrexate * With third space effusion * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

3-year Progression-free survival

Time frame: 3 years

Secondary Outcomes

Overall response rate

Time frame: 3 years

3-year overall survival

Time frame: 3 years

Data from ClinicalTrials.gov

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