Surveillance for Multifocal GGNs

ConditionsLung Ground-glass Opacities Active Surveillance

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of three or more GGNs (bilateral lesions are permitted).

All lesions have remained stable without regression or enlargement for at least 3 months.

The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and <=2cm.

CTR <=0.25 in all lesions.

Disqualifiers

History of any prior malignancies within the past 5 years.

History of lung surgery.

History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.

Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Trial population

Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Watchful waiting
Procedure/Surgery
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.

Treatment groups

370 Participants

are divided into 1 treatment group

Group A: Observation1 intervention

Trial outcomes

Primary outcomes

5-year overall survival

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

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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