Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
Phase 2
- Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
- Interventions
- Drug: Radiotherapy followed by chemotherapy
- Registration Number
- NCT01667302
- Lead Sponsor
- Fudan University
- Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
- Detailed Description
For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Age range 14-70 years old
- Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Without prior history of pancreatitis
- Adequate bone marrow and organ functions
Exclusion Criteria
- Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
- Pregnant or lactating women
- With contraindication of steroid including uncontrolled diabetes
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy followed by chemotherapy Radiotherapy followed by chemotherapy Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
- Primary Outcome Measures
Name Time Method 3-year Progression-free survival 3 years
- Secondary Outcome Measures
Name Time Method Overall response rate 3 years 3-year overall survival 3 years Safety 3 years
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳SHanghai, Shanghai, China