Surveillance for Multifocal GGNs
Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)
Fudan University
370 participants
Nov 1, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria4
- 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.
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Interventions
Conduct thoracic computed tomography scans every 12 months. The decision regarding surgery is based on the surgeon's evaluation of radiologic follow-up. The reference resection criteria encompass: a) Any lesion that progresses to a tumor diameter larger than 2cm or has CTR greater than 0.25. b) Clinical Tumor, node, metastasis (TNM) stage upstaging.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06097910