Back to resultsSelective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)
Primary Purpose
Lung Adenocarcinoma, Lymph Node Metastasis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Selective Lymph Node Dissection
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 with CTR>0.5 located in the apical segment; Non-lepidic predominant invasive NSCLC dignosed by frozen section; Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: Not cT1N0M0; Nodules not located in the apical segment or CTR≤0.5; Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.
Sites / Locations
- Chaoqiang DengRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Selective Lymph Node Dissection
Arm Description
Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment
Outcomes
Primary Outcome Measures
5-year overall survival
The event is defined as the death due to any causes.
Secondary Outcome Measures
Lymph node metastasis
the lymph node metastasis situation of each pathological subtype
5-year recurrence-free survival
The event is defined as the tumor recurrence.
The accuracy of frozen section
The concordance of frozen section and final pathological diagnosis for invasiveness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06031246
Brief Title
Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)
Official Title
Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: 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
April 1, 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-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment. The main questions it aims to answer are:
The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, Lymph Node Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
634 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selective Lymph Node Dissection
Arm Type
Experimental
Arm Description
Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment
Intervention Type
Procedure
Intervention Name(s)
Selective Lymph Node Dissection
Intervention Description
For patients with NSCLC with CTR>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected
Primary Outcome Measure Information:
Title
5-year overall survival
Description
The event is defined as the death due to any causes.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Lymph node metastasis
Description
the lymph node metastasis situation of each pathological subtype
Time Frame
5 years
Title
5-year recurrence-free survival
Description
The event is defined as the tumor recurrence.
Time Frame
5 years
Title
The accuracy of frozen section
Description
The concordance of frozen section and final pathological diagnosis for invasiveness
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 with CTR>0.5 located in the apical segment;
Non-lepidic predominant invasive NSCLC dignosed by frozen section;
Not receiving chemotherapy or radiotherapy before.
Exclusion Criteria:
Not cT1N0M0;
Nodules not located in the apical segment or CTR≤0.5;
Pre-invasive lung adenocarcinoma, lepidic predominant 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, M.D.
Phone
+86-13122677592
Email
fdudengcq@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiquan Chen, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaoqiang Deng
City
Shanghai
State/Province
Please Select
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoqiang Deng
Email
fdudengcq@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)
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