Early Interim Chemotherapy Response Evaluation by F-18 FDG PET/CT in Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles
研究概览
简要总结
Newly diagnosed diffuse large B cell lymphoma (DLBCL) patients who enter this study will receive baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) scan at the time of initial staging. The patients will be diagnosed and undergo initial staging according to The Catholic University Lymphoma Group (CULG) Protocol.
After 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) chemotherapy, early interim FDG PET/CT will be obtained after the patient recovers from nadir (usually 13 to 16 days after) following the administration of first cycle of R-CHOP,immediately before the second cycle of R-CHOP. The result of early interim FDG PET/CT study will not impact patient management, except in rare case where newly developed lesion is found and biopsy confirmed.
The same PET/CT system and analysis software will be used for all scans from baseline to surveillance for all patients enrolled in this study.
After 3 cycles of R-CHOP, a mid-therapy interim FDG PET/CT will be obtained. Patients with newly developed lesion will receive different chemotherapy regimen, while patients with stable disease, partial metabolic response or complete metabolic response will continue to receive 3 more cycles of R-CHOP.
After the completion of 6 cycles of R-CHOP, the patients will receive a FDG PET/CT scan for response assessment. Selected patients with persistent disease or very bulky tumor volume on initial staging images will receive additional radiation therapy.
The patients will be followed up every 3 months for 2 years from beginning of therapy. Physical examination and lab studies will be done usually every 3 months. Imaging studies will be performed every 3 months alternating between enhanced CT and FDG PET/CT and noted when different schedule is applied for surveillance.
The end points are changes in FDG uptake measurements between the baseline and early interim FDG PET/CT, and between baseline and mid-therapy interim FDG PET/CT scans; response assessment following completion of 6 cycles of R-CHOP with or without radiation therapy assessed by International Workshop Criteria (IWC)+PET and PET Response Criteria in Solid Tumors (PERCIST) guideline; and the 2 year disease free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20+ diffuse large B cell lymphoma confirmed
- •Therapy naïve for lymphoma
- •19 years or older
- •Written informed consent
排除标准
- •Cannot understand informed consent
- •Age under 19 years old
- •Previous chemotherapy or radiation therapy for lymphoma
- •Known pregnancy or urine/serum hCG (+)
- •Unable to lie down still on back for about 30 minutes
结局指标
主要结局
Change from baseline in summed peak standardized uptake value lean (SULpeak) after 3 cycles
时间窗: baseline and 3 cycles after starting chemotherapy, approximately 49 to 57 days after beginning R-CHOP
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and mid-therapy interim FDG PET/CT after 3 cycles in DLBCL patients
Change from baseline in summed SULpeak after 1 cycle
时间窗: baseline and 1 cycle after starting chemotherapy, approximately 13 to 16 days after beginning R-CHOP
Change in summed SULpeak between baseline FDG PET/CT before chemotherapy and early interim FDG PET/CT after 1 cycle of R-CHOP in DLBCL patients
次要结局
- 2 year disease free survival(up to 2 years after initial diagnosis)
- Quantitative response(after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP)
- Qualitative response(after chemotherapy with or without radiation therapy is finished, approximately 120 to 210 days after beginning R-CHOP)
研究者
Sung Hoon Kim
Chairman of Department of Radiology
The Catholic University of Korea