Comparison of Sublobar and Lobectomy in Small (2 Cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study

NCT06028412 | Enrolling By Invitation DMC

• 1 other identifier: XKT-Y-20221121
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

The early NSCLC（Non-small cell lung cancer） patients with partial solid nodules mainly composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and 0.5\<CTR（Consolidation tumor ratio）\<1, as indicated by preoperative thin slice CT, were selected as the study objects. The short-term and long-term effects of segmental resection and lobectomy under Thoracoscopy were compared to provide high-level evidence for the selection of surgical treatment methods for early NSCLC.

Conditions

NSCLC, Stage I

Outcome Measures

Primary Outcomes (1)

• DFS(Disease-free survival)

  Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.

  Follow up for 5 years for all patients after enrollment

Secondary Outcomes (4)

• OS (Overall survival)

  Follow up for 5 years for all patients after enrollment

• Pulmonary function test measure lung volume

  Respectively measure lung function at the 6th and 12th months after surgery

• Pulmonary function test measure rates of flow

  Respectively measure lung function at the 6th and 12th months after surgery

• Pulmonary function test measure gas exchange

  Respectively measure lung function at the 6th and 12th months after surgery

Study Arms (2)

Sublobar

EXPERIMENTAL

The minimize unit is the subsegment, the subloar group includes wedge resection, subsegmentectomy, segmentectomy. It is recommended to perform intraoperative lymph node pathology (not mandatory). If lymph node metastasis is positive, we must switch to lobectomy+system lymph node dissection. lymph node sampling, selective lymph node dissection or systematic lymph node dissection are allowed in this group.

Procedure: Sublobar

lobectomy

PLACEBO COMPARATOR

lobectomy and Systematic lymph node dissection

Procedure: Lobectomy

Interventions

Sublobar PROCEDURE

The minimize unit is the subsegment, the subloar group includes wedge resection, subsegmentectomy, segmentectomy. It is recommended to perform intraoperative lymph node pathology (not mandatory). If lymph node metastasis is positive, we must switch to lobectomy+system lymph node dissection. lymph node sampling, selective lymph node dissection or systematic lymph node dissection are allowed in this group.

Sublobar

Lobectomy PROCEDURE

lobectomy+system lymph node dissection

lobectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, regardless of gender;
• ECOG PS score 0-1 points (Attachment 3.4);
• Preoperative clinical staging for patients with suspected NSCLC lesions in Phase I (according to AJCC Eighth Edition staging standards, Attachment 3.5);
• Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm;
• Pre operative CT prompts 0.5\<CTR\<1.0;
• Good lung function (FEV1\>1.5 L or FEV1% ≥ 60%), able to tolerate both segmental resection and lobectomy;
• The number of pulmonary nodules that need to be processed is ≤ 3, and the nodules are located in the same side of the lung;
• Those who voluntarily sign the research informed consent form can comply with the research visit plan and other protocol requirements.

You may not qualify if:

• Hypertension and diabetes difficult to control;
• Pregnant or lactating women;
• Those who have received anti-tumor treatment (radiotherapy, chemotherapy, Targeted therapy, immunotherapy) before surgery;
• Previous history of lung surgery;
• Interstitial pneumonia, Pulmonary fibrosis or severe Emphysema;
• Those who undergo thoracotomy or change the surgical plan due to various reasons during surgery;
• Severe mental illness;
• Individuals with a history of severe heart disease, heart failure, myocardial infarction, or angina within the past 6 months;
• Active bacterial or fungal infections that are difficult to control;
• Individuals who have conducted other clinical trials in the three months prior to enrollment.
• The postoperative pathological result was Benign tumor;
• Postoperative pathological results of non NSCLC malignant tumors;
• Non small cell lung cancer confirmed histologically during operation, but with malignant Pleural effusion and pleural dissemination

Sponsors & Collaborators

• Xiaolong Yan, Dr.: lead

Study Sites (1)

The Second Affiliated Hospital of Air Force Medical University University of PLA

Xi'an, Shannxi, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• xiaolong yan

  The Second Affiliated Hospital of Air Force Medical University University of PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 8, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2023 10years

Locations

CN (1)