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

Phase 3

Recruiting

• Conditions: Lung Adenocarcinoma; Segmentectomy
• Interventions: Procedure: Segmentectomy

• Registration Number: NCT05717803
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-02-08
• Study Start: 2023-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 307

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Segmentectomy	Segmentectomy	Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.

Primary Outcome Measures

Name	Time	Method
5-year disease-free survival	5 years	The event is defined as the tumor recurrence or the death due to any causes.

Secondary Outcome Measures

Name	Time	Method
5-year overall survival	5 years	The event is defined as death due to any causes or last follow-up.
Lung function test	Half year and one year after surgical resection	FEV1/FVC
Surgery-related complications	From surgery to patient discharge or 30 days after surgery.	such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc
The site of tumor recurrence and metastasis	From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.	Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.
Segmentectomy completion rate	From the beginning of the surgery to the end of the surgery.	Proportion of patients who complete planned segmentectomy.
Radical segmentectomy (R0 resection) completion rate	From surgery to the release of the final pathology report, an average of two weeks.	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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China