ECTOP-1021：多发磨玻璃结节的主动监测

Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)
单臂、多中心、III 期试验
主要目的是通过采用观察等待方法而不是选择手术切除来评估多发磨玻璃结节患者的总体生存率。
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a active surveillance approach rather than opting for surgical resection.
The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.
该试验旨在证实以下假设：延迟手术直至 GGO 结节出现进展或满足某些标准，其预后与立即手术切除的患者相当，从而可能使许多患者完全避免手术。 如果任何病变出现进展（最大直径增加超过 1.5 毫米或出现实性成分）或由各机构确定，则满足手术标准。
Enrollment
370 estimated patients
Sex：All
Ages：18 to 75 years old

Inclusion and exclusion criteria

Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

• Demonstrates the following on thin-section computed tomography (TSCT) scan:
  
  
  • Presence of three or more GGNs (bilateral lesions are permitted).
  • All lesions have remained stable without regression or enlargement for at least 3 months.
  • The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and <=2cm.
  • CTR <=0.25 in all lesions.
  • No lymph node with a diameter >1cm in the mediastinal view.
  • Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
    
• Aged 18-75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has not previously undergo any anti-tumor drug or radiation therapy.
• Written informed consent.
  
  

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

• History of any prior malignancies within the past 5 years.
• History of lung surgery.
• History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
• Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.
  

纳入标准：

• 愿意参加研究，愿意遵守并有能力完成所有试验程序。
• 签署知情同意书时年龄18-80岁。
• 疑似 cN0M0 肺癌。
• ECOG 性能状态 0 或 1。
• CT 成像显示三个或更多持续性磨玻璃样混浊 (GGO)，符合以下标准：实变肿瘤比 (CTR) <= 0.25、最小直径 >=0.6cm、最大直径 <=2cm原发性病变。
• 结节不邻近胸膜，且无胸膜回缩。
• 既往未接受过任何形式的抗肿瘤药物治疗，也未接受过针对肺、肺门或纵隔的放射治疗。
  

排除标准：

• CTR > 0.25，或结节直径 < 0.6 cm 或 > 2 cm；
• 目前正在接受癌症相关治疗；
• 有恶性肿瘤病史。
  

进行胸腔计算机断层扫描每12个月进行一次扫描。
有关手术的决定是基于外科医生对放射学随访的评估。
参考切除标准包括：
a）任何肿瘤直径大于2厘米或CTR大于0.25的病变。
b）临床肿瘤，节点，转移（TNM）阶段升级。

Treatment:
Procedure: Watchful waiting

研究主要日期
学习开始 (实际的)
2023年11月1日
初级完成 (估计的)
2036年11月1日
研究完成 (估计的)
2036年11月1日

Fudan University Cancer Center

Active surveillance in Active Surveillance and Lung Ground-glass Opacities - Clinical Trials Registry - ICH GCP
Surveillance for Multifocal GGNs
Watchful waiting in Active Surveillance and Lung Ground-glass Opacities - Clinical Trials Registry - ICH GCP

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