Monitoring lung nodules without immediate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Haoxuan Wu, Dr.
• Email: haoxuanwu@hotmail.com
• Phone: 86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.