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

NCT06102161 | Not Yet Recruiting Phase 3

• 1 other identifier: WGGO
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Wedge Resection; Ground-glass Opacity

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

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

  5 years

Secondary Outcomes (6)

• 5-year recurrence-free survival

  5 years

• Postoperative lung function (FEV1)

  5 years

• Postoperative lung function

  5 years

• Sites of tumor recurrence and metastasis

  5 years

• Radical wedge resection (R0 resection) completion rate

  5 years

Study Arms (1)

Wedge resection

EXPERIMENTAL

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

Procedure: Wedge resection

Interventions

Wedge resection PROCEDURE

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.

Wedge resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

• Li T, Fu F, Zhang Y, Chen H. Protocol for a single-arm, multicenter, prospective, confirmatory phase III trial of wedge resection for invasive ground glass opacity-featured lung cancer with a size </=2 cm and a consolidation tumor ratio between 0.25 and 0.5 (ECTOP-1020 study). J Thorac Dis. 2024 Jul 30;16(7):4711-4718. doi: 10.21037/jtd-24-440. Epub 2024 Jul 9.

  PMID: 39144343 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Tong Li

CONTACT

+86 18813039287; litong_medical@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2030
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)