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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 465 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable

    Phase: Phase 3 to Not specified

    Primary and study completion dates: Sep 30, 2025 to Apr 4, 2027; Trial status: Completed to Active, Not Recruiting; Enrollment target: 701 to not stated; and 1 more

    Show all 5 changes in this update
    • Notable Phase: Phase 3 to Not specified
    • Notable Primary and study completion dates: Sep 30, 2025 to Apr 4, 2027
    • Minor Trial status: Completed to Active, Not Recruiting
    • Minor Enrollment target: 701 to not stated
    • Minor Site details revised at 4 of 386 sites

    Study Status, Study Design, Contacts/Locationsv465

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Dec 2025 to Sep 30, 2025

    Study Statusv464

  3. Notable

    Primary completion date: Apr 30, 2024 to Sep 30, 2025

    Completion date: Dec 2024 to Dec 2025

    Study Statusv463

  4. Minor

    Primary completion date changed from estimate of Apr 2024 to Apr 30, 2024

    Study Statusv462

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v461

Show 45 earlier versions

  1. Notable

    Start date: Jun 2007 to Oct 12, 2007

    Completion date: Dec 2024

    Study Statusv460

  2. Minor

    Study Status

    Re-verified, no change to tracked fields

    v459

  3. Notable

    Primary completion date: Mar 2021 to Apr 2024

    Study Statusv458

  4. Minor

    2 amendments

    2 re-verifications since 2019-07-01, no change to tracked fields

    v456-v457

  5. Minor

    Site details revised at 1 of 386 sites

    Study Status, Contacts/Locationsv455

  6. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Enrollment target: estimated 1258 to confirmed 701; Study sites: 425 to 386

    Study Status, Study Design, Contacts/Locationsv454

  7. Minor

    Study sites revised (425)

    Show what changed: Study sites
    Memorial Sloan Kettering Cancer Center Commack Memorial Sloan Kettering Cancer Center Rockville Centre

    Study Status, Contacts/Locationsv453

  8. Minor

    Study sites: 193 to 425

    Study Identification, Study Status, Contacts/Locationsv452

  9. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v451

  10. Minor

    Study sites: 65 to 193

    Study Status, Contacts/Locationsv450

  11. Notable

    Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology

    Study sites: 149 to 65; Interventions: therapeutic thoracoscopy (Procedure), videothoracoscopy (Procedure) to lobectomy (Procedure), segmentectomy or wedge resection (Procedure); Eligibility criteria expanded, about 24 words; and 4 more

    Show all 8 changes in this update
    • Notable Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology
    • Minor Study sites: 149 to 65
    • Minor Interventions: therapeutic thoracoscopy (Procedure), videothoracoscopy (Procedure) to lobectomy (Procedure), segmentectomy or wedge resection (Procedure)
    • Minor Eligibility criteria expanded, about 24 words
      Show what changed
      DISEASEPre-registration CHARACTERISTICSEligibility Criteria: Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria: Preoperative criteria Peripheral lung nodule ≤ 2 cm byon preoperative CT scan and presumed to be lung cancer. CenterThe center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal, or sagittal planplane. TumorPatients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible. The tumor location must be suitable for either lobar or s [...] [...]
    • Minor Secondary endpoints revised (3)
      Show what changed
      Overalloverall survival Raterate of loco-regional and systemic recurrence Pulmonarypulmonary function as measured by expiratory flow rate 6 months postoperatively
    • Minor Primary endpoint revised
      Show what changed
      Diseasedisease-free survival
    • Minor Study description expanded, about 1 word
      Show what changed
      OBJECTIVES: Primary Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy). Secondary Compare the overall survival of patients undergoing lobectomy vs sublobar rese [...] OUTLINE: This is a multicenter, randomized study. Patients a [...] ed on the maximum dimension determined from the preoperative CT scan), histology (squamous cell carcinoma vs adenocarcinoma [...] smokes]). Patients are randomized to 1 of 2 treatment arms. ArmFor Imore information, please see the Arms section. Pr [...] [...]
    • Minor Collaborators: 4 to 1
      Show what changed
      Radiation Therapy Oncology Group American College of Surgeons SWOG Cancer Research Network

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv449

  12. Minor

    Study sites: 147 to 149

    Study Status, Contacts/Locationsv448

  13. Minor

    Study sites: 146 to 147

    Study Status, Contacts/Locationsv447

  14. Minor

    Study sites: 147 to 146

    Study Status, Contacts/Locationsv446

  15. Minor

    Study sites: 148 to 147

    Study Status, Contacts/Locationsv445

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v444

  17. Minor

    Study sites: 147 to 148

    Study Status, Contacts/Locationsv443

  18. Minor

    Study sites: 148 to 147

    Study Status, Contacts/Locationsv442

  19. Minor

    Study sites: 147 to 148

    Study Status, Contacts/Locationsv441

  20. Minor

    Study sites: 148 to 147

    Study Status, Contacts/Locationsv440

  21. Minor

    Study sites: 139 to 148

    Study Status, Contacts/Locationsv439

  22. Minor

    Study sites: 138 to 139

    Study Status, Contacts/Locationsv438

  23. Minor

    Study sites: 120 to 138

    Study Status, Contacts/Locationsv437

  24. Minor

    Study sites: 119 to 120

    Study Status, Contacts/Locationsv436

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v435

  26. Minor

    Study sites: 118 to 119

    Study Status, Contacts/Locationsv434

  27. Minor

    Study sites: 117 to 118

    Study Status, Contacts/Locationsv433

  28. Minor

    Study sites: 116 to 117

    Study Status, Contacts/Locationsv432

  29. Minor

    Study sites: 115 to 116

    Study Status, Contacts/Locationsv431

  30. Minor

    Study sites: 116 to 115

    Study Status, Contacts/Locationsv430

  31. Minor

    Study sites: 119 to 116

    Study Status, Contacts/Locationsv429

  32. Minor

    Study sites: 120 to 119

    Study Status, Contacts/Locationsv428

  33. Minor

    Study sites: 110 to 120

    Study Status, Contacts/Locationsv427

  34. Minor

    Study sites: 109 to 110

    Study Status, Contacts/Locationsv426

  35. Minor

    Site contacts updated at 1 of 109 sites

    Study Status, Contacts/Locationsv425

  36. Minor

    Study sites: 108 to 109

    Study Status, Contacts/Locationsv424

  37. Minor

    Study sites: 107 to 108

    Study Status, Contacts/Locationsv423

  38. Minor

    Study sites: 106 to 107

    Study Status, Contacts/Locationsv422

  39. Minor

    Study sites: 105 to 106

    Study Status, Contacts/Locationsv421

  40. Minor

    Study sites: 106 to 105

    Study Status, Contacts/Locationsv420

  41. Minor

    Study sites: 108 to 106

    Study Status, Contacts/Locationsv419

  42. Minor

    Study sites: 107 to 108

    Study Status, Contacts/Locationsv418

  43. Minor

    Study sites: 106 to 107

    Study Status, Contacts/Locationsv417

  44. Minor

    Study sites: 107 to 106

    Study Status, Contacts/Locationsv416

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. 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.
Trial Details
NCT Number NCT00499330
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Lung Cancer
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov