NCT06102161Not yet recruitingPhase 3
Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- 5-year overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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;
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
5-year overall survival
Time Frame: 5 years
The event is defined as the death due to any causes.
Secondary Outcomes
- Postoperative lung function (FEV1)(5 years)
- Sites of tumor recurrence and metastasis(5 years)
- Radical wedge resection (R0 resection) completion rate(5 years)
- 5-year recurrence-free survival(5 years)
- Surgery-related complications(5 years)
- Postoperative lung function(5 years)
Investigators
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University
Study Sites (1)
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