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NCT Number: NCT06547710

Primary Tumor Resection for M1a Stage Lung Cancer

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.

Recruiting

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Key information

Conditions

Lung Cancer Metastatic Surgical Resection

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
  • Aged 18-80 years (including critical values) when signing the informed consent form;
  • ECOG score 0 or 1;
  • No previous lung cancer surgery;
  • Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
  • Occult pleural metastasis found during surgery;
  • First-time treatment and no radiotherapy or chemotherapy.

Exclusion criteria

  • The lesion cannot be completely removed surgically;
  • Cytological or histological pathology confirms other lung malignancies other than lung cancer;
  • Patients who have undergone lung cancer surgery before;
  • Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.

Treatment and study plan

Primary outcomes

  1. Median overall survival

    Time frame: About 10months.

    Median overall survival for M1a patients underging surgery.

Secondary outcomes

  1. 2-year overall survival

    Time frame: 2 years

    2-year overall survival

  2. 5-year overall survival

    Time frame: 5 years

    5-year overall survival

  3. FEV1 and FVC

    Time frame: 0.5 year

    Preoperative lung function test

Study contacts

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

Fangqiu Fu, MD

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial

Acronym: ECTOP-1023

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jul 8, 2026

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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