Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04944563

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2022-04-05

1120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether segmentectomy is as effective as lobectomy for treating patients with early-stage non-small cell lung cancer that is 2 cm or smaller and located in the middle third of the lung. This study aims to determine if segmentectomy has similar long-term cancer control and survival outcomes compared to lobectomy, expanding on previous research focused on tumors in the outer third of the lung. Participants will be randomly assigned to receive either segmentectomy or lobectomy surgery. Both procedures aim to remove the tumor with clear margins (R0 resection). The study monitors patients over several years to compare outcomes between the two surgical options. During the study, researchers will assess participants' disease-free survival over five years as the main outcome. They will also track complications within 30 days after surgery, lung function during the first year, and overall survival at three and five years. The total follow-up period is up to five years after recruitment, with regular evaluations and lung function tests at specific intervals.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18-75 years old
  • Tumor size between 6 mm and 20 mm
  • Consolidation-to-tumor ratio (CTR) greater than 0.25 and less than 1
  • Tumor center located in the middle third of the lung field
  • ECOG performance score of 0, 1, or 2
  • Lung function with forced expiratory volume in 1 second (FEV1) at least 1 L and at least 70%
  • Both segmentectomy and lobectomy can achieve complete tumor removal (R0 resection)
  • No serious heart or lung complications and able to tolerate both surgeries
  • No lymph node or distant metastasis
  • Single tumor nodule or additional nodules smaller than microinvasive tumors
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Tumor located in the right middle lobe
  • History of other cancers within the last 5 years (except early-stage thyroid cancer)
  • Received any anti-tumor therapy before surgery, including chemotherapy, radiation, or targeted therapy
  • Serious mental illness
  • Pregnant or breastfeeding women
  • Recent congestive heart failure, heart attack, or severe coronary artery stenosis within 6 months
  • History of stroke or brain hemorrhage within 6 months
  • Use of systemic corticosteroids within 1 month
  • Predicted surgical margin less than 2 cm or tumor size issues on 3D-CT bronchial angiography
  • Other conditions making participation unsuitable

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 30 days

Participants undergo either segmentectomy or lobectomy surgery to remove lung tumors.

Approximately 1 surgery visit and follow-up visits during the first 30 days after surgery

Post-operative Follow-up

Duration - Up to 5 years

Participants have their pulmonary function assessed and are monitored for disease-free survival and overall survival after surgery.

Visits at 3, 6, and 12 months for pulmonary function assessment, and additional visits for disease and survival monitoring up to 5 years

Trial Site Locations

Total: 1 location

1

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

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

Z

Zhihua Li, M.D.

W

Weibing Wu, M.D.

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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Published Research Related To This Trial

Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503).

Nasser K Altorki, Xiaofei Wang, Dennis Wigle...

https://pubmed.ncbi.nlm.nih.gov/30442588

A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L).

Kenichi Nakamura, Hisashi Saji, Ryu Nakajima...

https://pubmed.ncbi.nlm.nih.gov/19933688

Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy.

Yasuhiro Tsutani, Yoshihiro Miyata, Haruhiko Nakayama...

https://pubmed.ncbi.nlm.nih.gov/24551879