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

Phase 3RecruitingNCT05717803

Fudan University307 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

307

Conditions

Segmentectomy Lung Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

5-year disease-free survival

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

Time frame: 5 years

Secondary Outcomes

Lung function test

FEV1/FVC

Time frame: Half year and one year after surgical resection

5-year overall survival

The event is defined as death due to any causes or last follow-up.

Time frame: 5 years

The site of tumor recurrence and metastasis

Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.

Time frame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.

Segmentectomy completion rate

Proportion of patients who complete planned segmentectomy.

Time frame: From the beginning of the surgery to the end of the surgery.

Radical segmentectomy (R0 resection) completion rate

According to the postoperative pathology report of the patients, the proportion of patients with no residual tumor after radical segmentectomy accounted for all patients who underwent segmentectomy.

Time frame: From surgery to the release of the final pathology report, an average of two weeks.

Surgery-related complications

such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc

Time frame: From surgery to patient discharge or 30 days after surgery.