Actively Recruiting

Phase Not Applicable
Age: 20Years - 79Years
All Genders
NCT04937283

Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-04-13

690

Participants Needed

14

Research Sites

482 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.

CONDITIONS

Official Title

Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Who Can Participate

Age: 20Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 20-79 years old, both male or female
  • Tumor size \u2264 2cm on preoperative CT scan
  • Peripheral solitary nodule or associated lesion is minimally invasive adenocarcinoma (MIA) or less invasive lesion
  • Preoperative CT shows nodules are non-pure ground glass nodules (consolidation to tumor ratio \u2265 0.25)
  • Intraoperative frozen section confirms invasive lung adenocarcinoma with micropapillary and solid subtype negative (\u2264 5%)
  • Intraoperative frozen section shows resection margins free of tumor cells
  • Lung function can tolerate both segmentectomy and lobectomy (FEV1 > 1.5L or FEV1% \u2265 60%)
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Voluntary participation with signed informed consent and ability to comply with follow-up and study requirements
Not Eligible

You will not qualify if you...

  • Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25)
  • Nodule is close to lung hilus preventing segmentectomy
  • Intraoperative frozen section shows micropapillary and solid subtype positive (> 5%)
  • Intraoperative frozen section confirms adenocarcinoma in situ or minimally invasive adenocarcinoma
  • Preoperative imaging or EBUS indicates lymph node positive metastasis
  • Preoperative imaging shows distant metastasis
  • Severe heart, liver, or kidney damage (grade 3-4, ALT/AST over 3 times normal, creatinine over normal)
  • Other malignant tumors
  • Pregnant, planning pregnancy, or lactating females (urine HCG > 2500 IU/L indicating early pregnancy)
  • Prior chemotherapy, radiation, or other therapy; participation in other tumor clinical trials within 3 months
  • Investigator assessment determines unsuitability for trial participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 14 locations

1

Anhui Chest Hospital

Hefei, Anhui, China

Actively Recruiting

2

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Actively Recruiting

3

Nanyang Central Hospital

Nanyang, Henan, China

Actively Recruiting

4

The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China, 216002

Actively Recruiting

5

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 226001

Actively Recruiting

6

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Actively Recruiting

7

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Actively Recruiting

8

Shandong Public Health Clinical Center

Jinan, Shandong, China

Actively Recruiting

9

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

10

Huadong Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

11

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

12

Huzhou Central Hospital

Huzhou, Zhejiang, China

Actively Recruiting

13

Ningbo First Hospital

Ningbo, Zhejiang, China

Actively Recruiting

14

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

H

Hang Su

CONTACT

C

Chang Chen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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