A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Radiotherapy alone
- Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
- Sponsor
- Fudan University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- 3-year Progression-free survival
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Ye Guo
Assocaite Director of Medical Oncology Department
Fudan University
Eligibility Criteria
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
Arms & Interventions
Radiotherapy alone
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Intervention: Radiotherapy alone
Concurrent chemoradiation
Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
Intervention: Radiotherapy alone
Concurrent chemoradiation
Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
Intervention: Concurrent chemoradiation
Outcomes
Primary Outcomes
3-year Progression-free survival
Time Frame: 3 years
Secondary Outcomes
- 3-year overall survival(3 years)
- Overall response rate(3 years)