A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Radiotherapy followed by chemotherapy
- Conditions
- Extranodal NK/T-cell Lymphoma, Nasal Type
- Sponsor
- Fudan University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 3-year Progression-free survival
- Last Updated
- 13 years ago
Overview
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.
Investigators
Ye Guo
Assocaite Director of Medical Oncology Department
Fudan University
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Radiotherapy followed by chemotherapy
Outcomes
Primary Outcomes
3-year Progression-free survival
Time Frame: 3 years
Secondary Outcomes
- Overall response rate(3 years)
- 3-year overall survival(3 years)
- Safety(3 years)