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NCT03066297Active, not recruiting

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

A Prospective Study to Optimize the Extent of Pulmonary Resection According to the Decision-Making Algorithm in Patients With Clinical Stage IA Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 6 Dec 2023

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1018 (actual)
First submitted
15 Feb 2017
Start date
15 Feb 2017
Primary completion date
15 Feb 2027
Lead sponsor
Samsung Medical Center
Diseases
Lung cancer
NCT number
NCT03066297

What you commit to

  • Study type: Observational
  • Participants enrolled: 1018
  • From 15 Feb 2017 to the primary completion date, 15 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Bilobectomy, sleeve resection, pneumonectomy, concomitant wedge resection, or concomitant thoracic procedure (including cardiac surgery) is performed.

Other illness

  • Histologic diagnosis other than NSCLC (such as small cell lung cancer, carcinoid, pulmonary lymphoma, or other benign lung disease, etc).
  • M1a disease is confirmed intraoperatively or postoperatively.
  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.