Active Surveillance for Limited GGNs

N/ANot Yet RecruitingNCT06394037

Fudan University387 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

387

Conditions

Lung Ground-glass Opacities Active Surveillance

Interventions

Active surveillancePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

5-year overall survival

The event is defined as the death due to any causes.

Time frame: 5 years

Secondary Outcomes

10-year overall survival

The event is defined as the death due to any causes.

Time frame: 10 years

Data from ClinicalTrials.gov

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