Active Surveillance for Limited GGNs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2038-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Ground-glass Opacities Active Surveillance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

Active surveillance

Intervention Type PROCEDURE

Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

Interventions

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Active surveillance

Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

1. Presence of one or two 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 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. Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
3. Aged 18-75 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Written informed consent.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No