Lung Ground-glass Opacities, Active Surveillance
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREWatchful waiting
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.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients eligible for enrollment in the study are required to meet all the following criteria. 1. Demonstrates the following on thin-section computed tomography (TSCT) scan: 1. Presence of three or more GGNs (bilateral lesions are permitted). 2. All lesions have remained stable without regression or enlargement for at least 3 months. 3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter \>=0.6cm and \<=2cm. 4. CTR \<=0.25 in all lesions. 5. No lymph node with a diameter \>1cm in the mediastinal view. 6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions. 2. Aged 18-75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Has not previously undergo any anti-tumor drug or radiation therapy. 5. Written informed consent.
Exclusion criteria
Patients will be excluded if they meet any of the following criteria. 1. History of any prior malignancies within the past 5 years. 2. History of lung surgery. 3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases. 4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years | The event is defined as the death due to any causes. |
Countries
China
Contacts
Primary ContactHaoxuan Wu, Dr.
Outcome results
None listed