Status:
NOT_YET_RECRUITING
Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)
Lead Sponsor:
Fudan University
Conditions:
Lung Cancer
Wedge Resection
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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;
- Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
- 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;
- 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;
- peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
- cT1N0M0 tumors;
- Complete tumor resection by wedge resection as assessed by the surgeon;
- Not receiving chemotherapy or radiotherapy before.
Exclusion
- Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
- CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
- Cannot be completely resected by wedge resection;
- Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
- Receiving lung cancer surgery before;
- Receiving radiotherapy or chemotherapy.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT06102161
Start Date
November 1 2023
End Date
November 1 2030
Last Update
October 26 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China