Lung Adenocarcinoma, Segmentectomy
Conditions
Brief 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.
Interventions
PROCEDURESegmentectomy
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.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease-free survival | 5 years | The event is defined as the tumor recurrence or the death due to any causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years | The event is defined as death due to any causes or last follow-up. |
| The site of tumor recurrence and metastasis | From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years. | Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded. |
| Lung function test | Half year and one year after surgical resection | FEV1/FVC ratio |
| Radical segmentectomy (R0 resection) completion rate | From surgery to the release of the final pathology report, an average of two weeks. | According to the postoperative pathology report of the patients, the proportion of patients with no residual tumor after radical segmentectomy accounted for all patients who underwent segmentectomy. |
| Surgery-related complications | From surgery to patient discharge or 30 days after surgery. | such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc |
| Segmentectomy completion rate | From the beginning of the surgery to the end of the surgery. | Proportion of patients who complete planned segmentectomy. |
Countries
China
Contacts
Primary ContactFangqiu Fu, M.D.
Outcome results
None listed