NCT00915096已完成不适用
High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
Lymphoma Study Association22 个研究点 分布在 2 个国家目标入组 121 人开始时间: 2007年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 22
- 主要终点
- Predictive value of PET on progression-free survival
研究概览
简要总结
The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
- •Patients who have not previously been treated for this disease,
- •Introducing one of the criteria for high tumor burden,
- •Patients aged over 18 and under 80 years,
- •Patients whose ECOG condition is ≤ 2,
- •Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
- •Patient had the PET examination less than a month before the start of chemotherapy.
排除标准
- •Patients with lymphoma who have already transformed or been treated for this disease,
- •Patients whose lymphoma is stage 3b,
- •Patients with impaired central nervous system,
- •Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
- •Patients who have undergone major surgery during the 28 days preceding the inclusion,
- •Patients with low kidney and/or liver function,
- •Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
- •Patients whose life expectancy ≤ 6 months,
- •Patients sensitive or allergic to murine products,
- •Patients who participated in another clinical trial during the 30 days preceding the recording,
- •Patients with other medical problems or psychological succeptibles interfere with the study,
- •Patients under adult supervision.
结局指标
主要结局
Predictive value of PET on progression-free survival
时间窗: 2 years
次要结局
- Comparison of PET results to treatment response (Cheson criteria)(30 weeks)
- Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation(30 weeks)
- Correlation of PET data with FLIPI index score(Baseline)
- Correlation of PET data with histopathological data (including the use of immunohistochemical markers)(Baseline)
- Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria(30 weeks)
- Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow(Baseline)
研究者
研究点 (22)
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