Active Surveillance for Limited GGNs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active surveillance.
- Who it may be relevant to
- Registry conditions: Lung Ground-glass Opacities, Active Surveillance. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)
Overview
This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate 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
- Procedure Active surveillance
Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.
Primary outcome measures
- 5-year overall survival [Time frame: 5 years]
Secondary outcome measures (1)
- 10-year overall survival [Time frame: 10 years]
Eligibility 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 one or two 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 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.
- Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
- Aged 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Written informed consent.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06394037 · ECTOP-1028