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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy alone

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

Group Type ACTIVE_COMPARATOR

Radiotherapy alone

Intervention Type RADIATION

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

Concurrent chemoradiation

Concurrent chemoradiation

Chemotherapy:

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

Group Type EXPERIMENTAL

Radiotherapy alone

Intervention Type RADIATION

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

Concurrent chemoradiation

Intervention Type DRUG

Concurrent chemoradiation

Chemotherapy:

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

Interventions

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Radiotherapy alone

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

Intervention Type RADIATION

Concurrent chemoradiation

Concurrent chemoradiation

Chemotherapy:

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

Intervention Type DRUG

Other Intervention Names

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MTX

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No