Ground-glass Opacity, Lung Cancer, Wedge Resection
Conditions
Brief summary
This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.
Interventions
PROCEDUREWedge resection
Wedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer.
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
1. Patients who sign the informed consent form and are willing to complete the study according to the plan; 2. Aged from 18 to 80 years old; 3. ECOG equals 0 or 1; 4. Not receiving lung cancer surgery before; 5. Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma; 6. 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; 7. The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm; 8. peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field. 9. cT1N0M0 tumors; 10. Complete tumor resection by wedge resection as assessed by the surgeon; 11. Not receiving chemotherapy or radiotherapy before.
Exclusion criteria
1. Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma. 2. CTR is not between 0.25-0.5 or nodule size greater than 2 cm; 3. Cannot be completely resected by wedge resection; 4. Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically; 5. Receiving lung cancer surgery before; 6. Receiving radiotherapy or chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years | The event is defined as the death due to any causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative lung function (FEV1) | 5 years | forced expiratory volume in one second (FEV1) |
| Postoperative lung function | 5 years | forced vital capacity (FVC) |
| 5-year recurrence-free survival | 5 years | The event is defined as the tumor recurrence. |
| Radical wedge resection (R0 resection) completion rate | 5 years | — |
| Surgery-related complications | 5 years | — |
| Sites of tumor recurrence and metastasis | 5 years | — |
Countries
China
Contacts
Primary ContactTong Li
Outcome results
None listed