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

Fudan University

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Concurrent chemoradiation; Radiation: Radiotherapy alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01667289

LMTG 12-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Radiotherapy alone

Active Comparator group

Description:

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

Treatment:

Radiation: Radiotherapy alone

Concurrent chemoradiation

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy alone

Drug: Concurrent chemoradiation