Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)

Study Overview
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Brief Summary
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This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are: The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm; The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.

Official Title
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Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial

Conditions
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Segmentectomy, Lung Adenocarcinoma

Intervention / Treatment
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* Procedure: Segmentectomy


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; Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively; Ground glass-dominant lung nodules Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm; cN0 without distant metastasis; Tumors could be completely resected assed by surgeons; Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: CTR is not 0-0.5, or size is not 2-3cm; Tumors could not be completely resected assed by surgeons; Not 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: Segmentectomy<br>Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm. | Procedure: Segmentectomy<br>* The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.<br>* Other names: Segment removal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year disease-free survival | The event is defined as the tumor recurrence or the death due to any causes. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function test | FEV1/FVC | Half year and one year after surgical resection |