Back to resultsSublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)
Primary Purpose
Lung Adenocarcinoma, Frozen Section, Sublobar Resection
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sublobar Resection
Sponsored by
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Not cT1N0M0; Cannot be compeletly resected by sublobar resection; Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.
Sites / Locations
- Fudan University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sublobar resection
Arm Description
Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
Outcomes
Primary Outcome Measures
5-year recurrence-free survial
The event is defined as the tumor recurrence.
Secondary Outcome Measures
5-year overall survial
The event is defined as the death due to any causes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06031181
Brief Title
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)
Official Title
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, Frozen Section, Sublobar Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sublobar resection
Arm Type
Experimental
Arm Description
Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
Intervention Type
Procedure
Intervention Name(s)
Sublobar Resection
Intervention Description
Sublobar Resection includes sementectomy and wedge resection
Primary Outcome Measure Information:
Title
5-year recurrence-free survial
Description
The event is defined as the tumor recurrence.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
5-year overall survial
Description
The event is defined as the death due to any causes.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Not cT1N0M0;
Cannot be compeletly resected by sublobar resection;
Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
Receiving lung cancer surgery before;
Receiving radiotherapy or chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaoqiang Deng
Phone
+86-13122677592
Email
fdudengcq@163.com
Facility Information:
Facility Name
Fudan University Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Haiquan, MD
Phone
+86-21 64175590
Ext
1707
Email
hqchen1@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)
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