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RecruitingNCT06634966Updated Oct 10, 2024

Segmentectomy for Solid-dominant Lung Cancer

A Phase 3 interventional study of Segmentectomy in Segmentectomy and Lung Adenocarcinoma, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2024, registered Oct 2024).
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
277
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Segmentectomy
  • Lung Adenocarcinoma
03

In context

Adenocarcinoma of Lung

303 studies on the registry are indexed under Adenocarcinoma of Lung; 78 are open to participants now.

This study's planned enrollment of 277 is above the median of 63 across 212 interventional studies indexed under Adenocarcinoma of Lung.

Browse Adenocarcinoma of Lung studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
277 participants (estimated)

Study arms

  • Experimental
    Segmentectomy

    Segmentectomy is performed for solid-dominant invasive lung cancer with size of 2-3cm.

    Procedure: Segmentectomy

Interventions

  • ProcedureSegmentectomy

    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.

    Also known as: Segment resection

06

What researchers measure

Primary outcomes

  1. 5-year disease-free survival

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

    Time frame: 5 years

Secondary outcomes

  1. Lung function test

    FEV1/FVC ratio

    Time frame: Half year and one year after surgical resection

  2. 5-year overall survival

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

    Time frame: 5 years

  3. The site of tumor recurrence and metastasis

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

    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.

  4. Segmentectomy completion rate

    Proportion of patients who complete planned segmentectomy.

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

  5. Radical segmentectomy (R0 resection) completion rate

    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.

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

  6. Surgery-related complications

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

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

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai, China
    • Fangqiu Fu, M.D. · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06634966
Lead sponsor
Fudan University
Responsible party
Haiquan Chen (Haiquan Chen, Fudan University) — Principal investigator
First posted
Oct 10, 2024
Start date
Jul 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 10, 2024

Study contacts

Fangqiu Fu, M.D.
Contact
fufangqiu12@163.com
+86-13122677592
Haiquan Chen, M.D.
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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