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Trial Title:
Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)
NCT ID:
NCT06102161
Condition:
Lung Cancer
Wedge Resection
Ground-glass Opacity
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Wedge resection
Description:
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.
Arm group label:
Wedge resection
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.
Criteria for eligibility:
Criteria:
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.
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
Start date:
November 2023
Completion date:
November 2030
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/NCT06102161
