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

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06031181
• Collaborator: (none)
• Enrollment: 390
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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 theraputic effect of sublobar resection for AIS/MIA dignosed by intraoperative frozen section.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma; Frozen Section; Sublobar Resection	Procedure: Sublobar Resection	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 390 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
• Actual Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Jan 1, 2026
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sublobar resection Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section	Procedure: Sublobar Resection; Sublobar Resection includes sementectomy and wedge resection

Outcome Measures

Primary Outcome Measures

1. 5-year recurrence-free survial [5 years]

   The event is defined as the tumor recurrence.

Secondary Outcome Measures

1. 5-year overall survial [5 years]

   The event is defined as the death due to any causes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 compeletly 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiquan Chen, Director in the Department of Thoracic Surgery, FUSCC, Fudan University
• ClinicalTrials.gov Identifier: NCT06031181
• Other Study ID Numbers: SAFROS
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung; Adenocarcinoma in Situ

Study Results

No Results Posted as of Sep 11, 2023