GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study.
Yang Zhu, Shu Tian, Lan Xu...
https://pubmed.ncbi.nlm.nih.gov/34806163Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06314334
A Multicenter, Randomized, Controlled Phase II Study of Combined Sequential Chemotherapy and Radiation Therapies for Early-stage Natural Killer/T-cell Lymphoma (IE/IIE)
Led by Fudan University · Updated on 2026-04-09
210
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying early-stage extranodal NK/T-cell lymphoma, nasal type (NKTCL), a fast-growing cancer common in East Asian populations, often linked to EBV infection and mainly affecting the nasal area. The trial aims to compare the effectiveness and safety of three different treatment approaches combining chemotherapy, immunotherapy, and radiotherapy to find the best option for patients. This is a Phase II randomized controlled study focusing on 24-month progression-free survival as the main outcome. Participants are randomly assigned to one of three treatment groups: Group A receives four cycles of Sintilimab combined with pegaspargase alongside concurrent radiotherapy; Group B undergoes four cycles of PGemOx chemotherapy followed by sequential radiotherapy; Group C has two initial cycles of GELAD chemotherapy, then radiotherapy, followed by two additional GELAD cycles. Radiotherapy is delivered as intensity-modulated therapy (IMRT) with doses of 50-56Gy. During the study, patients are closely monitored with periodic assessments using PET/CT scans and bone marrow exams according to Lugano 2014 criteria. Researchers will evaluate progression-free survival over 24 months, along with other outcomes such as response rate at 24 weeks, overall survival, event-free survival, and treatment-related adverse events over up to 60 months. Patients’ organ function and overall health status are regularly checked to ensure safety throughout the trial period, which may last several years.
CONDITIONS
Brief Title
Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with extranodal NK/T-cell lymphoma, nasal type (NKTCL) based on WHO-2016 pathological criteria
- Primary tumor located in upper respiratory or digestive tract regions (nasal cavity, sinuses, nasopharynx, oropharynx, oral cavity)
- Clinical stage IE or IIE confirmed by PET/CT and bone marrow exam per Lugano 2014 criteria
- At least one measurable lesion or lesion assessable by PET/CT
- No prior chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ and bone marrow function as defined by ANC ≥1.0×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥90g/L, liver enzymes and bilirubin within specified limits, serum creatinine ≤1.5× upper limit normal, plasma fibrinogen ≥1.5g/L, left ventricular ejection fraction ≥50%, no acute myocardial infarction or significant arrhythmia
- Willingness to comply with study protocol, follow-up, and tests
You will not qualify if you...
- Co-infection with HCV, HIV, or HBV with plasma HBV-DNA >10^3/ml
- History of pancreatitis
- Acute or systemic infections requiring intravenous antibiotic treatment
- Severe complications such as hemophagocytic syndrome or disseminated intravascular coagulation
- Significant organ dysfunction including respiratory failure, NYHA class ≥2 heart failure, decompensated liver or kidney dysfunction, uncontrolled hypertension or diabetes, recent cardiovascular thrombotic or hemorrhagic events
- History of autoimmune diseases unsuitable for immune checkpoint inhibitor treatment
- Pregnant or breastfeeding women
- Psychiatric disorders
- Known allergies to chemotherapy drugs used in this study
- Other tumors requiring surgery or chemotherapy within past 6 months
- Current use of other experimental drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 12 to 24 weeks depending on treatment group
Participants receive one of three treatment strategies involving chemotherapy and radiotherapy. Group A receives 4 cycles of Sintilimab combined with pegaspargase (each cycle lasting 3 weeks) with concurrent radiotherapy starting within 21 days after the first treatment. Group B receives 4 cycles of PGEMOX chemotherapy (each cycle lasting 3 weeks) followed by radiotherapy within 4 weeks after the last chemotherapy cycle. Group C receives 2 cycles of GELAD chemotherapy (each cycle lasting 3 weeks), then radiotherapy within 4 weeks, followed by 2 additional cycles of GELAD chemotherapy.
Multiple visits during chemotherapy cycles and radiotherapy sessions, schedule depending on assigned group
Follow-up
Duration - Up to 60 months
Participants are monitored for disease progression, response to treatment, and long-term safety outcomes for up to 60 months after treatment completion.
Regular follow-up visits for assessments over 5 years
Trial Site Locations
Total: 7 locations
1
Cancer Hospital of Fujian Province
Fuzhou, Fujian, China, 350003
Actively Recruiting
2
Nantong Cancer Hospital
Nantong, Jiangsu, China, 226006
Actively Recruiting
3
Shanghai Eye Ear Nose and Throat Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
5
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
7
People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
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Research Team
R
Rong Tao, MD
C
Chuanxu Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Sequential P-GEMOX and radiotherapy for early-stage extranodal natural killer/T-cell lymphoma: A multicenter study.
Yuchen Zhang, Shuyun Ma, Jun Cai...
https://pubmed.ncbi.nlm.nih.gov/34449095Pegaspargase Combined with Concurrent Radiotherapy for Early-Stage Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: A Two-Center Phase II Study.
Hua Wang, Liang Wang, Chun Li...
https://pubmed.ncbi.nlm.nih.gov/32627928