Watchful Waiting for Patients With Multifocal Ground-glass Opacities (ECTOP-1021)

Study Overview
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Brief Summary
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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 watchful waiting approach rather than opting for surgical resection.

Detailed Description
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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. Surgical criteria are met if any of the lesions exhibit progression (with a maximal diameter increase of more than 1.5mm or the apperance of a solid component) or as determined by each institution.

Official Title
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Watchful Waiting for Patients With Multifocal Ground-glass Opacities: a Single-arm, Multi-center, Phase III Trial (ECTOP-1021)

Conditions
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Lung Ground-glass Opacities, Watchful Waiting

Intervention / Treatment
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* Procedure: Watchful waiting


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria. Demonstrates the following on CT scan: Suspected cN0M0 lung cancer. Presence of three or more ground-glass opacities (Bilateral lesions are permitted). All lesions have remained stable without regression or enlargement for at least 3 months. The primary lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and <=2cm. A consolidation-to-tumor ratio <= 0.25 in all lesions. Not adjacent to the pleura and no sign of pleural retraction in all 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. History of lung surgery. History of interstitial pneumonia, pulmonary fibrosis or other pulmonary diseases. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br> | Procedure: Watchful waiting<br>* Conduct thoracic computed tomography scans every 12 months. If a solid component emerges of if there is an increase in the size of any lung nodules, the treamtent approach would involve surgery of radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years |