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Trial Title:
Segmentectomy for Solid-dominant Lung Cancer
NCT ID:
NCT06634966
Condition:
Segmentectomy
Lung Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma of Lung
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Segmentectomy
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.
Arm group label:
Segmentectomy
Other name:
Segment resection
Summary:
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP),
numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic
effect of segmentectomy for solid-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 solid-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.
Criteria for 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 0.5 to 1, 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 0.5-1, 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Fangqiu Fu, M.D.
Start date:
July 1, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06634966
