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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Frozen Section; Sublobar Resection; Lung Adenocarcinoma

Treatments: Procedure: Sublobar Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT06031181

SAFROS

Details and patient eligibility

About

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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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390 participants in 1 patient group

Sublobar resection

Experimental group

Description:

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

Treatment:

Procedure: Sublobar Resection