Back to resultsSegmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
Primary Purpose
Segmentectomy, Lung Adenocarcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Segmentectomy
Sponsored by
About this trial
This is an interventional treatment trial for Segmentectomy
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; Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively; Ground glass-dominant lung nodules Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm; cN0 without distant metastasis; Tumors could be completely resected assed by surgeons; Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: CTR is not 0-0.5, or size is not 2-3cm; Tumors could not be completely resected assed by surgeons; Not lung adenocarcinoma diagnosed cytologically or pathologically; Receiving lung cancer surgery before; Receiving radiotherapy or chemotherapy.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Segmentectomy
Arm Description
Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.
Outcomes
Primary Outcome Measures
5-year disease-free survival
The event is defined as the tumor recurrence or the death due to any causes.
Secondary Outcome Measures
Lung function test
FEV1/FVC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05717803
Brief Title
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
Official Title
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (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-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:
The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;
The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Segmentectomy, Lung Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
307 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Segmentectomy
Arm Type
Experimental
Arm Description
Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.
Intervention Type
Procedure
Intervention Name(s)
Segmentectomy
Other Intervention Name(s)
Segment resection, Segment removal
Intervention Description
The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.
Primary Outcome Measure Information:
Title
5-year disease-free survival
Description
The event is defined as the tumor recurrence or the death due to any causes.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Lung function test
Description
FEV1/FVC
Time Frame
Half year and one year after surgical resection
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;
Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
Ground glass-dominant lung nodules
Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
cN0 without distant metastasis;
Tumors could be completely resected assed by surgeons;
Not receiving chemotherapy or radiotherapy before.
Exclusion Criteria:
CTR is not 0-0.5, or size is not 2-3cm;
Tumors could not be completely resected assed by surgeons;
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
Fangqiu Fu, M.D.
Phone
+86-13122677592
Email
fufangqiu12@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
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangqiu Fu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
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