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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Extranodal NK/T-cell Lymphoma, Nasal Type

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Trial Information

A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year Progression-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 12-01

NCT ID:

NCT01667289

Start Date:

June 2012

Completion Date:

June 2017

Related Keywords:

  • Extranodal NK/T-cell Lymphoma, Nasal Type
  • NK/T-cell lymphoma
  • Methotrexate
  • Radiotherapy
  • Concurrent chemoradiation
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, Extranodal NK-T-Cell

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