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

NCT06031181 | Recruiting Phase 3

• 1 other identifier: SAFROS
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Adenocarcinoma; Frozen Section; Sublobar Resection

Outcome Measures

Primary Outcomes (1)

• 5-year recurrence-free survival

  The event is defined as the tumor recurrence.

  5 years

Secondary Outcomes (1)

• 5-year overall survival

  5 years

Study Arms (1)

Sublobar resection

EXPERIMENTAL

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

Procedure: Sublobar Resection

Interventions

Sublobar Resection PROCEDURE

Sublobar Resection includes segmentectomy and wedge resection

Sublobar resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Resectable peripheral cT1N0M0 tumors;
• 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;
• Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
• Not receiving chemotherapy or radiotherapy before.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Zheng S, Deng C, Li Y, Zhang Y, Chen H. Sublobar resection for adenocarcinoma in situ and minimally invasive adenocarcinoma diagnosed by intraoperative frozen section (ECTOP-1019): a study protocol of prospective, single-arm, multicenter, phase III study. J Thorac Dis. 2024 Sep 30;16(9):6286-6291. doi: 10.21037/jtd-24-623. Epub 2024 Sep 18.

  PMID: 39444881 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Central Study Contacts

Chaoqiang Deng

CONTACT

+86-13122677592; fdudengcq@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: March 31, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)