RecruitingPhase 2NCT06314334

Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma

A Multicenter, Randomized, Controlled Phase II Screening Study of Combined Sequential Chemotherapy and Radiation Therapies for Early-stage Natural Killer/T-cell Lymphoma (IE/IIE)


Sponsor

Fudan University

Enrollment

210 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of sequential chemotherapy followed by radiation therapy for patients with early-stage NK/T-cell lymphoma — a rare and aggressive type of lymphoma that most commonly affects the nasal cavity and upper airway. Researchers want to find the best sequencing and response-adapted approach for this cancer. **You may be eligible if...** - You have been diagnosed with NK/T-cell lymphoma (NKTCL) confirmed by biopsy - Your cancer is located in the upper airway (nasal cavity, sinuses, nasopharynx, oropharynx, or mouth) - Your disease is early stage (IE or IIE) based on PET/CT and bone marrow assessment - You are between 18 and 75 years old - You have not received any prior treatment for lymphoma - Your general health is acceptable (ECOG 0–2) with adequate organ and bone marrow function **You may NOT be eligible if...** - You have received prior chemotherapy, radiation, or immunotherapy for lymphoma - Your cancer has spread beyond the upper airway lymphoma stage criteria - You have poor organ function that would prevent safe chemotherapy 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSintilimab+Pegaspargase

1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1;

DRUGP-GemOx

1. pegaspargase 2000U/m\^2, capped at 3750U on day 1, intramuscular; 2. gemcitabine 1.0g/m\^2 on day 1 and day 8, intravenous drip; 3. oxaliplatin 130mg/m\^2 on day 1, intravenous drip

DRUGGELAD

1. gemcitabine 1.0g/m\^2 on day 1, intravenous drip; 2. etoposide 60mg/m\^2 on day 1-3, intravenous drip; 3. pegaspargase 2000U/m\^2, capped at 3750U on day 1,intramuscular; 4. dexamethasone 20mg on day 1-4, intravenous drip.

RADIATIONIMRT

Intensity modulated radiotherapy (50-56Gy)


Locations(7)

Cancer Hospital of Fujian Province

Fuzhou, Fujian, China

Nantong Cancer Hospital

Nantong, Jiangsu, China

Shanghai Eye Ear Nose and Throat Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

People's Hospital of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06314334


Related Trials