NCT06097910

Surveillance for Multifocal GGNs

Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 370 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a active surveillance approach rather than opting for surgical resection.

Detailed description

The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

Conditions

• Lung Ground-glass Opacities
• Active Surveillance

Interventions

Type	Name	Description
PROCEDURE	Watchful waiting	Conduct thoracic computed tomography scans every 12 months. The decision regarding surgery is based on the surgeon's evaluation of radiologic follow-up. The reference resection criteria encompass: a) Any lesion that progresses to a tumor diameter larger than 2cm or has CTR greater than 0.25. b) Clinical Tumor, node, metastasis (TNM) stage upstaging.

Timeline

• Start date: 2023-11-01
• Primary completion: 2036-11-01
• Completion: 2036-11-01
• First posted: 2023-10-24
• Last updated: 2025-01-31

Locations

1 site across 1 country: China