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NCT Number: NCT05717803

Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:

* The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm; * The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.

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Key information

Conditions

Segmentectomy Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Adenocarcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Fangqiu Fu, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who sign the informed consent form and are willing to complete the study according to the plan;
  • Aged from 18 to 80 years old;
  • ECOG equals 0 or 1;
  • Not receiving lung cancer surgery before;
  • Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
  • Ground glass-dominant lung nodules
  • Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
  • cN0 without distant metastasis;
  • Tumors could be completely resected assed by surgeons;
  • Not receiving chemotherapy or radiotherapy before.

Exclusion criteria

  • CTR is not 0-0.5, or size is not 2-3cm;
  • Tumors could not be completely resected assed by surgeons;
  • Not lung adenocarcinoma diagnosed cytologically or pathologically;
  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Treatment and study plan

Segmentectomy

Procedure

The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.

Other names: Segment resection, Segment removal

Primary outcomes

  1. 5-year disease-free survival

    Time frame: 5 years

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

Secondary outcomes

  1. Lung function test

    Time frame: Half year and one year after surgical resection

    FEV1/FVC

  2. 5-year overall survival

    Time frame: 5 years

    The event is defined as death due to any causes or last follow-up.

  3. The site of tumor recurrence and metastasis

    Time frame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.

    Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.

  4. Segmentectomy completion rate

    Time frame: From the beginning of the surgery to the end of the surgery.

    Proportion of patients who complete planned segmentectomy.

  5. Radical segmentectomy (R0 resection) completion rate

    Time frame: From surgery to the release of the final pathology report, an average of two weeks.

    According to the postoperative pathology report of the patients, the proportion of patients with no residual tumor after radical segmentectomy accounted for all patients who underwent segmentectomy.

  6. Surgery-related complications

    Time frame: From surgery to patient discharge or 30 days after surgery.

    such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc

Study contacts

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

Fangqiu Fu, M.D.

CONTACT

[email protected]

+86-13122677592

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Feb 8, 2023
Registry last updated
Jun 3, 2024

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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