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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102161
• Other study ID #: WGGO
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2023
• Est. completion date: November 2030

Study information

• Verified date: October 2023
• Source: Fudan University
• Contact: Tong Li
• Phone: +86 18813039287
• Email: litong_medical[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 286
• Est. completion date: November 2030
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Wedge Resection

Intervention

Procedure:
• Wedge 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival	The event is defined as the death due to any causes.	5 years
Secondary	5-year recurrence-free survival	The event is defined as the tumor recurrence.	5 years
Secondary	Postoperative lung function (FEV1)	forced expiratory volume in one second (FEV1)	5 years
Secondary	Postoperative lung function	forced vital capacity (FVC)	5 years
Secondary	Sites of tumor recurrence and metastasis		5 years
Secondary	Radical wedge resection (R0 resection) completion rate		5 years
Secondary	Surgery-related complications		5 years