Optimal Extent of Pulmonary Resection in Clinical Stage IA Non-Small Cell Lung Cancer

NCT03066297 | Active Not Recruiting

• 1 other identifier: 2016-12-116
• Study Type: observational
• Target: 1,018
• Locations: 1 country
• Sites: 1

Brief Summary

The investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer. The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.

Conditions

Stage IA Non-small Cell Lung Cancer

Keywords

Clinical stage IA non-small cell lung cancer; Lobectomy; Segmentectomy; Wedge resection; Sublobar resection; Limited resection

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  the time from the date of the operation until the first recurrence or the last follow-up.

  5 years

Secondary Outcomes (8)

• Overall survival (OS)

  5 years

• Rate of loco-regional recurrence

  5 years

• Rate of systemic recurrence

  5 years

• Postoperative FEV1 (Forced expiratory volume in 1 second; Liter)

  6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date

• Postoperative DLco (Diffusing capacity of the lung for carbon monoxide; mL/mmHg/min)

  6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date

Study Arms (3)

Lobectomy

Lobectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Segmentectomy

Segmentectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Procedure: Extent of pulmonary resection

Wide wedge resection

Wide wedge resection will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Procedure: Extent of pulmonary resection

Interventions

Extent of pulmonary resection PROCEDURE

Extent of pulmonary resection selected based on the institutional decision-making algorithm

Segmentectomy; Wide wedge resection

Eligibility Criteria

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

Study Population

Patients who are planned to undergo surgery for clinical stage IA non-small cell lung cancer

You may qualify if:

• The following features should be fulfilled at preoperative thin-section CT scans
• Solitary lung nodule
• Lesion size is 3cm or less in its maximal dimension of the entire tumor
• The center of the tumor is located in the outer third of the lung field in either the transverse, coronal, or sagittal plane
• Lung cancer is suspected (or NSCLC if tissue diagnosis already obtained)
• Clinical stage T1a-bN0M0 (according to 7th AJCC staging system)
• Absence of proximal segmental or lobar bronchial involvement.
• NSCLC must be confirmed in intraoperative frozen section biopsies or postoperative pathologic examinations if the lesion was not histologically confirmed before operation.
• Age ≥ 18 years and \< 75 years.
• ECOG performance status 0-1.
• The patient should have adequate cardiopulmonary reserve to tolerate lobectomy (ppo FEV1 \> 40% and ppo DLCO \> 40% or VO2 max \> 15ml kg-1 min-1)
• No prior chemotherapy or thoracic radiotherapy for any malignancy.
• No prior malignancy within 5 years from study entry (except for non-melanoma skin cancer, superficial bladder cancer, thyroid cancer or carcinoma in situ of the uterine cervix).
• The patient agrees to participate in the study and signs the informed consent form.

You may not qualify if:

• Histologic diagnosis other than NSCLC (such as small cell lung cancer, carcinoid, pulmonary lymphoma, or other benign lung disease, etc).
• Hilar or mediastinal lymph node metastasis suspected on imaging studies (CT or PET/CT) or confirmed preoperatively by EBUS or mediastinoscopy.
• Parietal pleura, chest wall, or mediastinal invasion is confirmed intraoperatively or postoperatively.
• M1a disease is confirmed intraoperatively or postoperatively.
• Bilobectomy, sleeve resection, pneumonectomy, concomitant wedge resection, or concomitant thoracic procedure (including cardiac surgery) is performed.
• Synchronous or metachronous multiple cancers (within the past 5 years).
• Interstitial lung disease or severe pulmonary emphysema which makes it impossible to tolerate either lobectomy or sublobar resection.
• Active bacterial or fungal infection.
• Uncontrolled systemic disease which makes the patient medically unfit for thoracic surgery such as unstable angina, recent myocardial infarction, congestive heart failure, or end-stage renal or liver disease.
• Serious mental illness or psychosis.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Hong Kwan Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Department of Thoracic and Cardiovascular Surgery

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 28, 2017
• Study Start: February 15, 2017
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)