Monitoring lung nodules without immediate surgery

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

This study is testing if watching lung nodules closely instead of doing surgery right away can help patients with multifocal ground-glass opacities live just as long.

Quick facts

• Study type: Observational
• Enrollment: 370 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06097910 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with multifocal ground-glass opacities (GGNs) and evaluates the effectiveness of an active surveillance approach instead of immediate surgical resection. Conducted under the Eastern Cooperative Thoracic Oncology Project, the trial aims to determine if delaying surgery until nodules show progression can provide similar survival outcomes as those who undergo surgery right away. The study involves monitoring patients over time to assess the stability of their GGNs and to identify any changes that may necessitate surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with three or more stable GGNs that meet specific imaging criteria.

Not a fit: Patients with rapidly progressing GGNs or those requiring immediate intervention will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow many patients to avoid unnecessary surgeries while still maintaining a good prognosis.

How similar studies have performed: Other studies have suggested that active surveillance can be a viable option for certain patients with lung nodules, indicating potential success for this approach.

Eligibility criteria

Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

   1. Presence of three or more GGNs (bilateral lesions are permitted).
   2. All lesions have remained stable without regression or enlargement for at least 3 months.
   3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter \>=0.6cm and \<=2cm.
   4. CTR \<=0.25 in all lesions.
   5. No lymph node with a diameter \>1cm in the mediastinal view.
   6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
2. Aged 18-75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Has not previously undergo any anti-tumor drug or radiation therapy.
5. Written informed consent.

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

1. History of any prior malignancies within the past 5 years.
2. History of lung surgery.
3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Haoxuan Wu, Dr.

Conditions Lung Ground-glass Opacities; Active Surveillance