Segmentectomy for Solid-dominant Lung Cancer

October 9, 2024 updated by: Haiquan Chen, Fudan University

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

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-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 solid-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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Fangqiu Fu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 0.5 to 1, 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 0.5-1, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Segmentectomy
Segmentectomy is performed for solid-dominant invasive lung cancer with size of 2-3cm.
Procedure: Segmentectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival
Time Frame: 5 years
The event is defined as the tumor recurrence or the death due to any causes.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: 5 years
The event is defined as death due to any causes or last follow-up.
5 years
Segmentectomy completion rate
Time Frame: From the beginning of the surgery to the end of the surgery.
Proportion of patients who complete planned segmentectomy.
From the beginning of the surgery to the end of the surgery.
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.
From surgery to the release of the final pathology report, an average of two weeks.
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
From surgery to patient discharge or 30 days after surgery.
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.
From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
Lung function test
Time Frame: Half year and one year after surgical resection
FEV1/FVC ratio
Half year and one year after surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Haiquan Chen, M.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECTOP-1025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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