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NCT Number: NCT06394037

Active Surveillance for Limited GGNs

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Demonstrates the following on thin-section computed tomography (TSCT) scan:
  • Presence of one or two 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 lesions.
  • No lymph node with a diameter >1cm in the mediastinal view.
  • Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
  • Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
  • Aged 18-75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Written informed consent.

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

  • 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.

Treatment and study plan

Active Surveillance

Procedure

Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery.

Primary outcomes

  1. 5-year overall survival

    Time frame: 5 years

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

Secondary outcomes

  1. 10-year overall survival

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Active Surveillance for Patients with Limited Ground-glass Nodules in China: a Prospective Multi-center Single-arm Trial (ECTOP-1028)

Important dates

Study start
2025
Primary completion
2038
Study completion
2038
First posted
May 1, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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