Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499330
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2007-07-10
Brief Title:
Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small 2 cm Peripheral Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OUTLINE This is a multicenter randomized study Patients are stratified according to tumor size 1 cm vs 1-15 cm vs 15-20 cm based on the maximum dimension determined from the preoperative CT scan histology squamous cell carcinoma vs adenocarcinoma vs other and smoking status never smoked smoked 100 cigarettes over lifetime vs former smoker smoked 100 cigarettes AND quit 1 year ago vs current smoker quit 1 year ago or currently smokes Patients are randomized to 1 of 2 treatment arms For more information please see the Arms section
Primary Objective
To determine whether DFS after sublobar resection segmentectomy or wedge is non-inferior to that after lobectomy in patients with small peripheral 2 cm NSCLC
Secondary Objectives
1 To determine whether overall survival OS after sublobar resection is non-inferior to that after lobectomy
2 To determine the rates of loco-regional and systemic recurrence exclusive of second primaries after lobar and sublobar resection
3 To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively
4 Imaging Substudy To explore the relationship between characteristics of the primary lung cancer as revealed by pre-operative CT and PET imaging and outcomes a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilarand mediastinal lymph nodes and an assessment of the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 5 years
Primary Objective
To determine whether DFS after sublobar resection segmentectomy or wedge is non-inferior to that after lobectomy in patients with small peripheral 2 cm NSCLC
Secondary Objectives
1 To determine whether overall survival OS after sublobar resection is non-inferior to that after lobectomy
2 To determine the rates of loco-regional and systemic recurrence exclusive of second primaries after lobar and sublobar resection
3 To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively
4 Imaging Substudy To explore the relationship between characteristics of the primary lung cancer as revealed by pre-operative CT and PET imaging and outcomes a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilarand mediastinal lymph nodes and an assessment of the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CALGB-140503 | None | None | None |
| CDR0000555324 | REGISTRY | None | None |
| NCI-2009-00447 | REGISTRY | NCI Clinical Trial Reporting Program | None |