Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003692
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
1999-11-01
Brief Title:
Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Video-Assisted Lobectomy for Peripheral no Greater Than 3 cm N0 Non-Small Cell Lung Cancer A Phase II Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-08
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 Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of performing video-assisted thoracic surgery VATS lobectomy without significant morbidity or perioperative mortality in patients with small no greater than 30 cm peripheral non-small cell lung cancer II Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients III Describe the complications associated with this procedure IV Describe the length of the operative procedure duration of chest tube stay and length of hospitalization in this patient population V Describe the survival and failure-free survival over a 5-year period in this patient population following this procedure
OUTLINE Patients undergo video-assisted thoracic surgery VATS lobectomy which requires 3 small incisions on the side of the chest The entire anatomic pulmonary lobe is removed as well as all peribronchial lymph nodes and anterior hilar lymph nodes If it is not possible to remove the lobe using the VATS approach then 1 of the incisions is converted to a standard thoracotomy Patients are followed every 4 months for the first 2 years and then every 6 months for the next 3 years
PROJECTED ACCRUAL A total of 135 patients will be accrued for this study within 3 years
OUTLINE Patients undergo video-assisted thoracic surgery VATS lobectomy which requires 3 small incisions on the side of the chest The entire anatomic pulmonary lobe is removed as well as all peribronchial lymph nodes and anterior hilar lymph nodes If it is not possible to remove the lobe using the VATS approach then 1 of the incisions is converted to a standard thoracotomy Patients are followed every 4 months for the first 2 years and then every 6 months for the next 3 years
PROJECTED ACCRUAL A total of 135 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000066795 | REGISTRY | NCI Physicians Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-39802 | None | None | None |
| E-C39802 | None | None | None |