Status:
RECRUITING
Surveillance for Multifocal GGNs
Lead Sponsor:
Fudan University
Conditions:
Lung Ground-glass Opacities
Active Surveillance
Eligibility:
All Genders
18-75 years
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 t...
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 resec...
Eligibility Criteria
Inclusion
- Inclusion 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 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 criteria 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.
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2036
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06097910
Start Date
November 1 2023
End Date
November 1 2036
Last Update
January 31 2025
Active Locations (1)
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1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032