A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Who Had Complete Remission as Assessed by PET-CT After Immune-chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- 2-Year Event Free Survival Rate
研究概览
简要总结
This study is a prospective, single center, phase II clinical study involving 108 patients with primary and late stage Diffuse Large B-cell Lymphoma complicated by large masses and extranodal involvement. The study aims to evaluate the efficacy of radiotherapy targeting large masses and extranodal involvement in treatment-naïve advanced DLBCL patients with large mass lesions and/or extranodal involvement after they had initially been treated with standard immunochemotherapy and received complete remission as assessed by PET-CT.
After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after their leaving the group, so as to obtain the relevant data and data of the 2-year Progression Free Survival, survival of the subjects and Treatment-related side effects.
详细描述
Safety analysis:
The safety analysis is mainly based on descriptive statistical analysis, which lists and describes the incidence, severity, correlation, risk and outcome of adverse events (AE) in this trial.
Efficacy analysis:
The Kaplan-Meier method will be used to draw the overall survival curve and the progression-free survival curve, and to estimate the median survival time, median progression-free survival period and their 95% confidence intervals.
Before starting the study, patients must read and sign the current version of informed consent form approved by the Ethics Committee (EC). All research steps must be carried out within the time window specified in the research schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Using the World Health Organization (WHO) classification of diseases, newly diagnosed diffuse large B-cell lymphoma with large masses (tumor diameter ≥ 7.5cm) and or extranodal involvement patients diagnosed by histology
- •Age: no limit, male or female;
- •ECOG score: 0-2
- •The laboratory meets the following requirements:
- •4.1 The bone marrow hematopoietic function is basically normal: WBC ≥ 3.5×10^9/L, ANC ≥ 1.0×10^9/L, PLT ≥ 75 ×10^9/L, Hb ≥ 80g/L;
- •4.2 Liver function: AST/ALT≤2×ULN, TBILI≤2×ULN;
- •4.3 Renal Function : creatinine clearance rate(Ccr) ≥50ml/min
- •Non-menopausal or non-surgical sterilization female patients of childbearing age must have a serum pregnancy test within 3 days before the first medication, and the result is negative; and they must be non-lactating. Female patients of childbearing age or male patients whose partners are women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after the last administration of the study drug;
- •Expected survival period ≥ 6 months;
- •The patient voluntarily joined the study and signed the informed consent;
排除标准
- •Serum pregnancy test positive or breastfeeding women;
- •Lymphoma patients with central nervous system (CNS) invasion;
- •Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA), cardiac function class III or IV; or cardiac left ventricular ejection fraction <50%;
- •Patients with ≥2 grade neuropathy;
- •Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases;
- •Patients with severe active infection who require systemic antibiotic treatment;
- •Have a history of serious neurological or psychiatric diseases, unable to participate in the trial normally, including dementia, epilepsy, severe depression and mania, etc.;
- •Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results;
- •Patients considered by the investigator to be unsuitable for enrollment;
研究组 & 干预措施
Radiation Group
Paients will be treated with 6-8 cycles (21 days per cycle) of standard R-CHOP chemotherapy.
After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after a patient's leaving the group, so as to obtain the relevant data including those for figuring up 2-year PFS and survival of subjects and any treatment-related side effects as well.
干预措施: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy (Drug)
Radiation Group
Paients will be treated with 6-8 cycles (21 days per cycle) of standard R-CHOP chemotherapy.
After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after a patient's leaving the group, so as to obtain the relevant data including those for figuring up 2-year PFS and survival of subjects and any treatment-related side effects as well.
干预措施: Radiotherapy beyond standard R-CHOP Chemotherapy (Radiation)
Non-radiation Group
Paients will be treated with 6-8 cycles (21 days per cycle) of standard R-CHOP chemotherapy, but after this treatment patients will not be further given radiation therapy.
干预措施: 6-8 cycles (21 days per cycle) of Standard R-CHOP chemotherapy (Drug)
结局指标
主要结局
2-Year Event Free Survival Rate
时间窗: 2-Year
The proportion of enrolled patients who are free of events such as death, disease progression, switch to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, and other events
2-Year Progression-Free Survival Rate
时间窗: 2-Year
The percentage of people who did not have new tumor growth or cancer spread during or after treatment.
次要结局
- 2-Year Overall Survival(2-Year)
- Adverse Events related to Radiotherapy(Adverse events that occur within 30 days)
- 2-Year Local Control Rate(2-Year)