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

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01667289
• Other study ID #: LMTG 12-01
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2012
• Last updated: March 2, 2013
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Progression-free survival		3 years	No
Secondary	Overall response rate		3 years	No
Secondary	3-year overall survival		3 years	No