Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)

Phase 3

Not yet recruiting

• Conditions: Wedge Resection; Ground-glass Opacity; Lung Cancer
• Interventions: Procedure: Wedge resection

• Registration Number: NCT06102161
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Study Start: 2023-11
• Primary Completion: 2025-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 286

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wedge resection	Wedge resection	Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 years	The event is defined as the death due to any causes.

Secondary Outcome Measures

Name	Time	Method
Radical wedge resection (R0 resection) completion rate	5 years
Sites of tumor recurrence and metastasis	5 years
Postoperative lung function (FEV1)	5 years	forced expiratory volume in one second (FEV1)
Surgery-related complications	5 years
5-year recurrence-free survival	5 years	The event is defined as the tumor recurrence.
Postoperative lung function	5 years	forced vital capacity (FVC)

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China