Menu
Not yet recruiting NCT06102161

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

Phase III Interventional Lung Cancer Wedge Resection Ground-glass Opacity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wedge resection.
Who it may be relevant to
Registry conditions: Lung Cancer, Wedge Resection, Ground-glass Opacity. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 5-year overall survival [Time frame: 5 years]
Secondary outcome measures (6)
  • 5-year recurrence-free survival [Time frame: 5 years]
  • Postoperative lung function (FEV1) [Time frame: 5 years]
  • Postoperative lung function [Time frame: 5 years]
  • Sites of tumor recurrence and metastasis [Time frame: 5 years]
  • Radical wedge resection (R0 resection) completion rate [Time frame: 5 years]
  • Surgery-related complications [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Publications

  • 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

Identifiers

NCT: NCT06102161 · WGGO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗