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NCT Number: NCT04944563

Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Liang Chen, M.D.

PRINCIPAL_INVESTIGATOR

Weibing Wu, M.D.

SUB_INVESTIGATOR

Zhihua Li, M.D.

CONTACT

[email protected]

+86-02568303743

About this study

Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged 18-75 years old;
  • 6 mm ≤ tumor size ≤ 20 mm;
  • 0.25 < CTR < 1;
  • Center of tumor located in the middle third of the lung field;
  • ECOG score of 0,1 or 2;
  • Lung function (FEV1 ≥ 1 L and ≥ 70%);
  • Both lung segmentectomy and lobectomy could achieve R0 resection;
  • No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
  • No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
  • Single tumor nodule or the concomitant nodule < microinvasive tumor;
  • Written informed consent.

Exclusion criteria

  • The tumor nodule is located in right middle lobe;
  • A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
  • Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
  • A serious mental illness;
  • Pregnant and lactating women;
  • Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
  • With the history of cerebral infarction or cerebral hemorrhage within 6 months;
  • With the history of sustained systemic corticosteroid therapy within 1 month;
  • The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
  • Other unsuitable situations;

Treatment and study plan

Segmentectomy

Procedure

Patients receive segmentectomy

Lobectomy

Procedure

Patients receive lobectomy

Primary outcomes

  1. 5-year Disease-Free Survival

    Time frame: From date of the recruitment, assessed up to 60 months

    The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

Secondary outcomes

  1. 30-day Morbidity and mortality rates

    Time frame: From date of the recruitment, assessed up to 30 days

    The rates of complications and death related to treatment during perioperative period

  2. Pulmonary function in the first year after surgery

    Time frame: From date of the 3rd, 6th, and 12th month after surgery

    The Forced expiratory volume in one second (FEV1) in liter

  3. 3-year Disease-Free-Survival

    Time frame: From date of the recruitment, assessed up to 36 months

    The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

  4. 5-year overall Survival

    Time frame: From date of the recruitment, assessed up to 60 months

    The time interval from randomization to death caused by any reason

Study contacts

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

Weibing Wu, M.D.

CONTACT

[email protected]

+86-025-68303743

Zhihua Li, M.D.

CONTACT

[email protected]

+86-025-68303743

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jun 29, 2021
Registry last updated
Apr 5, 2022

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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