NCT01667289

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-06-01
• Completion: 2017-06-01
• First posted: 2012-08-17
• Last updated: 2013-03-05

Locations

1 site across 1 country: China