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临床试验/NCT01619241
NCT01619241Unknown不适用

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

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ie Ryung Yoo

Chief of Nuclear Medicine department

The Catholic University of Korea

研究点 (1)

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