Clinical Usefulness and Prognostic Significance of Interim 18F-FDG PET/CT for the Treatment of Peripheral T Cell Lymphomas
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT will be prospectively investigated to determine whether it provided additional prognostic information and could be a positive predictable value for the treatment of PTCL.
详细描述
- Treatment protocol
- Patients with limited-stage (stage I/II) are treated with CHOP/CHOP-like chemotherapy [cyclophosphamide 750 mg/m2 i.v. on D1, vincristine 1.4 mg/m2 i.v. on D1, doxorubicin 50 mg/m2 i.v. on D1, and prednisolone 60 mg/m2 p.o. on D1-5] in standard doses every three weeks and three to four cycles of CHOP/CHOP-like chemotherapy followed by involved field radiation therapy (IFRT, 30 Gy). Patients with advanced-stage (stage III/IV) are treated with eight cycles of primary chemotherapy and patients greater than 65 years and/or those with a frail general condition were treated with only six cycles of primary chemotherapy if they achieved a complete response (CR) for the interim response.
- Response evaluation based on three parameters of visual, standard uptake value(SUV)-based and metabolic tumor volume (MTV)-based assessments
- We firstly classify patients with five-point scale (5-PS) by the interim PET/CT analysis based on the Deauville criteria12: 1, No uptake; 2, uptake ≤ mediastinum; 3, uptake > mediastinum but ≤ liver; 4, uptake moderately increased compared to the liver uptake at any site; 5, markedly increased uptake compared to the liver at any site and new sites or/and new sites of disease. Interim PET/CT image are graded as negative or positive by comparison of initial PET/CT and grade 1-3 considered as negative and grade 4-5 considered for positive.19 This grading process is independent of the size of the residual tumor.
Secondly, we classify the patients with the quantitative analysis of 18F-FDG uptake changes based on the percentage of SUVmax reduction between initial and interim PET/CT. On axial, coronal, or sagittal coregistered PET/CT slices, simple circular regions of interest (ROIs) were placed so as to cover the lesion or background. SUV measurements are corrected for body weight according to the following standard formula: Mean ROI activity (MBq/ml)
- [Injected dose (MBq)/Body weight (kg)].20 For each PET dataset, the maximum SUV (SUVmax) is defined as the highest SUV among all hypermetabolic tumor foci. SUVmax reduction rate (ΔSUVmax) is calculated as following:
ΔSUVmax (%) = 100 x [SUVmax (initial) - SUVmax (interim)]/SUVmax (initial)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Histologically proven PTCLs except primary cutaneous/subcutaneous panniculitis
- •ECOG performance status ≤ 2
- •Patients who are available to be performed PET/CT at diagnosis
- •No severe concomitant disease
排除标准
- •Patients who did not undergo PET/CT scans at diagnosis
- •Patients who have a primary CNS lymphoma
- •Patients who have a HIV or HTLV-1
- •Patients who could not receive primary chemotherapy
结局指标
主要结局
Progression-free survival
时间窗: From the treatment start time to the first recording of disease progression or death from any cause, which assessed up to 24 months.
Patients whose disease did not progress would be censored using the date at which they were last known to show no progress.
次要结局
未报告次要终点