Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)

Study Overview
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Brief Summary
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This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.

Official Title
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Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial

Conditions
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Lung Cancer, Wedge Resection, Ground-glass Opacity

Intervention / Treatment
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* Procedure: Wedge resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign the informed consent form and are willing to complete the study according to the plan; Aged from 18 to 80 years old; ECOG equals 0 or 1; Not receiving lung cancer surgery before; Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma; Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules; The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm; peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field. cT1N0M0 tumors; Complete tumor resection by wedge resection as assessed by the surgeon; Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma. CTR is not between 0.25-0.5 or nodule size greater than 2 cm; Cannot be completely resected by wedge resection; Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wedge resection<br>Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue. | Procedure: Wedge resection<br>* Wedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year recurrence-free survival | The event is defined as the tumor recurrence. | 5 years | 
| Postoperative lung function (FEV1) | forced expiratory volume in one second (FEV1) | 5 years | 
| Postoperative lung function | forced vital capacity (FVC) | 5 years | 
| Sites of tumor recurrence and metastasis |  | 5 years | 
| Radical wedge resection (R0 resection) completion rate |  | 5 years | 
| Surgery-related complications |  | 5 years |