跳至主要内容
临床试验/NCT02149576
NCT02149576已完成2 期

Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial

McMaster University2 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
313
试验地点
2
主要终点
Rate of therapeutic re-intervention within the first year after curative resection of lung cancer

研究概览

简要总结

After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival.

The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

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

  • Patients must be at minimum 18 years of age
  • Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
  • Patients must demonstrate the ability to understand English
  • Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

排除标准

  • Patients with residual gross or microscopic disease after surgery
  • Patients with pathological Stage III or Stage IV lung cancer

结局指标

主要结局

Rate of therapeutic re-intervention within the first year after curative resection of lung cancer

时间窗: One year after surgery

Defined by: 1) rate of curative intent radiation treatment after detection of recurrent or new primary lung cancer 2) rate of curative intent reoperation after detection of recurrent or new primary lung cancer. Measured by frequency of events.

次要结局

  • Rate of adherence to follow-up visits(One year after surgery)
  • Morbidity of associated interventions(One year after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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