Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

Phase 3

Recruiting

• Conditions: Sublobar Resection; Frozen Section; Lung Adenocarcinoma
• Interventions: Procedure: Sublobar Resection

• Registration Number: NCT06031181
• Lead Sponsor: Fudan University

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-13
• Primary Completion: 2026-01-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors;
6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
7. Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
8. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria

1. Not cT1N0M0;
2. Cannot be completely resected by sublobar resection;
3. Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sublobar resection	Sublobar Resection	Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section

Primary Outcome Measures

Name	Time	Method
5-year recurrence-free survival	5 years	The event is defined as the tumor recurrence.

Secondary Outcome Measures

Name	Time	Method
5-year overall survival	5 years	The event is defined as the death due to any causes.

Trial Locations

Locations (1)

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