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

A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667289

Enrollment

Registered

2012-08-17

Start date

2012-06-30

Completion date

2017-06-30

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

NK/T-cell lymphoma, Methotrexate, Radiotherapy, Concurrent chemoradiation

Brief summary

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.

Detailed 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.

Interventions

RADIATIONRadiotherapy alone

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

DRUGConcurrent chemoradiation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
3-year Progression-free survival	3 years

Secondary

Measure	Time frame
Overall response rate	3 years
3-year overall survival	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026