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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Wedge Resection; Ground-glass Opacity
• Intervention / Treatment: Procedure: Wedge resection

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tong Li; Phone Number: +86 18813039287; Email: litong_medical@163.com

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	The event is defined as the death due to any causes.	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: WGGO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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