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

Phase 2

Terminated

• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
• Interventions: Radiation: Radiotherapy alone; Drug: Concurrent chemoradiation

• Registration Number: NCT01667289
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-02
• Last Update Posted: 2013-03-05
• Primary Completion: 2015-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent chemoradiation	Radiotherapy alone	Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
Radiotherapy alone	Radiotherapy alone	Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Concurrent chemoradiation	Concurrent chemoradiation	Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Primary Outcome Measures

Name	Time	Method
3-year Progression-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
3-year overall survival	3 years
Overall response rate	3 years

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China