Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study

This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.

Study Overview

• Status: Active, not recruiting
• Conditions: IA Lung Adenocarcinoma; Combined Segmentectomy
• Intervention / Treatment: Procedure: Patients receive subsegmentectomy

• Study Type: Interventional
• Enrollment (Estimated): 688
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) , Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) PS score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy.

  (7) FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant metastasis were found in the preoperative clinical evaluation, (9) voluntary participation and informed consent were obtained;

Exclusion Criteria:

• (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple GGO considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combined segmentectomy	Procedure: Patients receive subsegmentectomy; Patients receive lobectomy
Placebo Comparator: lobectomy	Procedure: Patients receive subsegmentectomy; Patients receive lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival	This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died	2 years

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Collaborators: Wu Jieping Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: Union-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No