Actively Recruiting
Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL
Led by Sun Yat-sen University · Updated on 2024-05-09
90
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of concurrent chemoradiotherapy by using single-drug pegaspargase for patients with ENKTL in stage IE to IIE.
CONDITIONS
Official Title
Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed with extranodal NK/T-cell lymphoma and no prior treatment for this lymphoma
- Estimated survival time of at least 3 months
- Aged between 18 and 75 years
- Ann-Arbor stage IE to IIE lymphoma
- ECOG performance status between 0 and 2
- Judged suitable for concurrent chemoradiotherapy by clinicians
- No radiotherapy or hormone drugs received within 4 weeks before treatment
- No other drugs affecting ENKTL allowed after enrollment
- White blood cell count at least 3 x 10^9/L, neutrophil count at least 1.5 x 10^9/L, platelet count at least 100 x 10^9/L
- Serum creatinine 1.5 mg/dL or less, creatinine clearance rate at least 50 mL/min
- ALT and AST less than or equal to 3 times the normal upper limit, total bilirubin less than or equal to 2 times the normal upper limit
- Serum fibrinogen level at least 1.0 g/L
- Signed informed consent form
You will not qualify if you...
- Symptomatic central nervous system involvement or other malignant tumors
- Primary ENKTL lesion outside the upper respiratory or gastrointestinal tract
- Poor general condition or ECOG performance status greater than 2
- Pregnant or lactating women
- Potential fertility without willingness or use of effective contraception
- Known allergies to study drugs or their components
- Deemed unsuitable for concurrent chemoradiotherapy by doctors
- Active infection as determined by the researcher
- Concomitant diseases seriously risking patient safety or study completion
- History of neurological or psychiatric disorders including epilepsy or dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HuaWang
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hua Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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