4555S-07: C140503 NSCLC

CTSU C140503: A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (<=2 cm) Peripheral Non-Small Cell Lung Cancer

Type of Study
Cancer (Oncology) - Lung
Location
Swedish Cancer Institute
Short Description

Purpose: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria:

     

    • Preoperative criteria

       

       

      • Peripheral lung nodule ≤ 2 cm by CT scan

         

         

        • Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan

           

           

        • Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy)

           

         

      • No pure ground opacities or pathologically confirmed N1 or N2 disease

         

       

    • Intraoperative criteria

       

       

      • Histologically confirmed NSCLC

         

         

      • Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side

         

         

        • Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration

           

     

  • No evidence of locally advanced or metastatic disease

     

     

  • ECOG performance status 0-2

  • No prior chemotherapy or radiotherapy for this malignancy

More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org