The Role of F-18 FLT PET/CT for Selecting the Patients Who Need Maintenance Treatment After First-line Chemotherapy in Advanced Non-small Cell Lung Cancers
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.
详细描述
Standard therapy for patients with advanced NSCLC is platinum based doublet chemotherapy. Current first-line chemotherapy is usually limited to 4-6 cycles, as prolonging treatment does not result in additional benefit and may often cause further toxicity. Until recently, treatment guidelines recommended withholding administration of later-line systemic anti-cancer treatment until disease progression.
There are several reports suggesting that maintenance therapy following first-line chemotherapy offers improved survival in advance stage patients. This approach involves the administration of an active treatment immediately after first-line chemotherapy, thus maintaining the clinical benefit initially obtained. However, drug related toxicity and costs are of great concern. There may also be patients with less aggressive disease where an immediate transition to maintenance therapy after first-line results in overtreatment.
Therefore, selecting patients who require more aggressive treatment or earlier intervention is necessary.
If FLT PET/CT can discriminate the patients with shorter progression free survival and overall survival in this pilot study, patients could be selected for more aggressive or earlier treatment such as maintenance therapy, and the investigators could expect to prolong survival while reducing the adverse events and costs that will accompany inconsequential therapy with FLT PET/CT.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced non-small cell lung cancer (stage IIIB, IV)
- •at least one measurable lesion
- •performance status (ECOG) 0-2
- •1st-line platinum chemotherapy and no progression
排除标准
- •mixed small cell and non-small cell
- •uncontrolled brain metastasis
- •previous malignancy within 5 years (except basal cell carcinoma of skin, carcinoma in situ of uterine cervix)
- •pregnant or breast feeding
- •pemetrexed chemotherapy
结局指标
主要结局
overall survival
时间窗: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year
次要结局
- time to progression(from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year)
研究者
Ie Ryung Yoo
Chief of Nuclear Medicine department
The Catholic University of Korea
