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TERMINATEDPHASE2

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

NCT01667289•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 1, 2012

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2017

Last Updated

March 5, 2013

Enrollment

ACTUAL participants

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Radiotherapy alone

RADIATION

Concurrent chemoradiation

DRUG

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

NCT03493451

Peripheral T Cell LymphomaPTCL+17 more

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TERMINATEDPHASE1/PHASE2

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

NCT04509466

Extranodal NK/T-cell Lymphoma, Nasal Type

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma

Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma