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

Lung Adenocarcinoma Clinical Trial

Official title:

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031181
• Other study ID #: SAFROS
• Status: Recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: Chaoqiang Deng
• Phone: +86-13122677592
• Email: fdudengcq[@]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-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 31, 2030
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma in Situ
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Procedure:
• Sublobar Resection
Sublobar Resection includes segmentectomy and wedge resection

Locations

Country	Name	City	State
China	Fudan University 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 recurrence-free survival	The event is defined as the tumor recurrence.	5 years
Secondary	5-year overall survival	The event is defined as the death due to any causes.	5 years