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

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06102161
• Collaborator: (none)
• Enrollment: 286
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Wedge Resection; Ground-glass Opacity	Procedure: Wedge resection	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 286 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Nov 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wedge resection Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.	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.

Outcome Measures

Primary Outcome Measures

1. 5-year overall survival [5 years]

   The event is defined as the death due to any causes.

Secondary Outcome Measures

1. 5-year recurrence-free survival [5 years]

   The event is defined as the tumor recurrence.

2. Postoperative lung function (FEV1) [5 years]

   forced expiratory volume in one second (FEV1)

3. Postoperative lung function [5 years]

   forced vital capacity (FVC)

4. Sites of tumor recurrence and metastasis [5 years]

5. Radical wedge resection (R0 resection) completion rate [5 years]

6. Surgery-related complications [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiquan Chen, Director in the Department of Thoracic Surgery, FUSCC, Fudan University
• ClinicalTrials.gov Identifier: NCT06102161
• Other Study ID Numbers: WGGO
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Oct 26, 2023