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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Lung Adenocarcinoma; Segmentectomy

Treatments: Procedure: Segmentectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05717803

FUSCC2211

Details and patient eligibility

About

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.

Enrollment: 307 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

307 participants in 1 patient group

Segmentectomy

Experimental group

Description:

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

Treatment:

Procedure: Segmentectomy