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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717803
• Other study ID #: FUSCC2211
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: Fudan University
• Contact: Fangqiu Fu, M.D.
• Phone: +86-13122677592
• Email: fufangqiu12[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 307
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Segmentectomy

Intervention

Procedure:
• Segmentectomy
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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year disease-free survival	The event is defined as the tumor recurrence or the death due to any causes.	5 years
Secondary	Lung function test	FEV1/FVC	Half year and one year after surgical resection
Secondary	5-year overall survival	The event is defined as death due to any causes or last follow-up.	5 years
Secondary	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.	From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
Secondary	Segmentectomy completion rate	Proportion of patients who complete planned segmentectomy.	From the beginning of the surgery to the end of the surgery.
Secondary	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.	From surgery to the release of the final pathology report, an average of two weeks.
Secondary	Surgery-related complications	such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc	From surgery to patient discharge or 30 days after surgery.