Overview
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.
Description
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.
Eligibility
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.