The Beneficial Value of 18F FDG PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients: the NVALT31-PET Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 690
- 试验地点
- 30
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computerized Tomography (18F FDG PET/CT) versus follow-up with conventional CT surveillance.
Participants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET/CT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group.
Other tasks include:
- filling in quality of life (QOL) questionnaires at every time point;
- participating in an interview evaluating the addition of the 18F FDG PET/CT scans (optional);
- collecting blood at the follow-up time points for our secondary endpoint (optional).
Researchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET/CT scans are (cost-)effective.
详细描述
Stage III non-small cell lung cancer (NSCLC) patients are at high risk of developing recurrences (50-78%) during follow-up. With more effective treatments available for patients with oligometastatic disease, early detection of tumor recurrence can prolong survival and health-related quality of life and thereby lower the disease burden. With the use of 18F FDG PET/CT during follow-up, recurrences may be detected earlier at an oligometastatic state when curative-intent treatment is still possible.
Primary objective:
- The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance.
The secondary objectives of this study are:
- To compare the 2-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance (interim analysis);
- To compare the number of detected (symptomatic and asymptomatic) recurrences of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;
- To compare the event-free survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;
- To determine the cost-effectiveness of 18F FDG PET/CT versus conventional CT-based surveillance during follow-up of stage III NSCLC patients;
- To compare the effect of 18F FDG PET/CT versus conventional CT-based surveillance on health-related quality of life during follow-up of stage III NSCLC patients;
- To assess the beneficial value of ctDNA in the detection of recurrences during follow-up in stage III NSCLC patients;
- To identify patients' experiences with the additional 18F FDG PET/CT scans in the follow-up of stage III NSCLC patients.
- To assess differences in type of treatment following recurrence during follow-up in stage III NSCLC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •To be eligible to participate in this study, a subject must meet all of the following criteria at the timing of randomization:
- •Cytological or histologically proven stage III non-small cell lung cancer before start of curative intent treatment
- •Treated with curative intent and started follow-up care
- •All adjuvant treatments are permitted as co-intervention during follow-up care
- •Age 18 years or older
- •ECOG Performance Status classification 0-2 at moment of inclusion
- •Written and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Life expectancy shorter than 6 months at the end of curative intent treatment
- •Evidence of recurrence after end of curative intent treatment and before randomization (4 months follow-up)
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.
结局指标
主要结局
Overall Survival (OS)
时间窗: 3 years after end of curative intent treatment
Overall survival (OS) will be defined as time from end of curative intent treatment until death or loss to follow-up or end of study defined as 3 years after end of curative treatment.
次要结局
- Number of detected symptomatic and asymptomatic recurrences(Up to 3 years after end of curative intent treatment)
- Event-free survival (EFS)(3 years after end of curative intent treatment)
- Quality-adjusted life-years ((QALY's) for the cost-effectiveness analysis (CEA))(Up to 3 years after end of curative intent treatment)
- Hospital and medical resource use (for the CEA)(Up to 3 years after end of curative intent treatment)
- Productivity losses (for the CEA)(Up to 3 years after end of curative intent treatment)
- Health-related quality of life (HRQOL)(Up to 3 years after end of curative intent treatment collected around the follow-up scans.)
- Patients' evaluation of the 18F FDG PET/CT scans(Up to 3 years after end of curative intent treatment collected around the follow-up scans.)
- Blood samples(Up to 3 years after end of curative intent treatment collected around the follow-up scans.)