RecruitingPhase 2NCT06406556

Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL

Evaluate the Safety and Efficacy of Pegaspargase-based Concurrent Chemoradiotherapy in the Treatment of Early Stage Extranodal NK/T Cell Lymphoma


Sponsor

Sun Yat-sen University

Enrollment

90 participants

Start Date

Mar 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial studies a combination of chemotherapy and radiation therapy for patients newly diagnosed with a rare cancer of the nasal passages and throat called Natural Killer/T-cell lymphoma (ENKTL). Researchers are testing whether adding a PEG-asparaginase-based chemotherapy to radiation improves outcomes. **You may be eligible if...** - You are 18 to 75 years old - You have been newly diagnosed with ENKTL (no prior treatment) - Your disease is at an early stage (stage IE or IIE) - You are in good general health (ECOG score 0–2) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have received prior treatment for ENKTL - You received radiation or steroids within 4 weeks before enrollment - Your estimated survival is less than 3 months - Your blood counts or kidney/liver function do not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPegaspargase combined with concurrent radiotherapy.

Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks). 4 courses of pegaspargase were performed after CCRT.


Locations(1)

HuaWang

Guangzhou, Guangdong, China

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NCT06406556


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