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NCT Number: NCT06097910

Surveillance for Multifocal GGNs

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Chen Haiquan, MD

CONTACT

[email protected]

+86-21 64175590 ext. 1707

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.

Inclusion criteria

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 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.
  • 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.
  • Aged 18-75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has not previously undergo any anti-tumor drug or radiation therapy.
  • Written informed consent.

Exclusion criteria

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

Watchful waiting

Procedure

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.

Primary outcomes

  1. 5-year overall survival

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haoxuan Wu, Dr.

CONTACT

[email protected]

86-021-64175590 ext. 63189

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2036
Study completion
2036
First posted
Oct 24, 2023
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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