Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002624
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
VIDEO ASSISTED WEDGE RESECTION VAR AND RADIOTHERAPY FOR HIGH RISK T1 NON-SMALL CELL LUNG CANCER A PHASE II STUDY
Status:
COMPLETED
Status Verified Date:
2016-07
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 Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery
PURPOSE Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function
PURPOSE Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function
Detailed Description:
OBJECTIVES
Determine the feasibility of video-assisted thoracoscopic wedge resection VAR followed by radiotherapy in patients with stage I non-small cell lung cancer and cardiopulmonary dysfunction
Determine the incidence of locoregional recurrence in patients treated with this regimen
Determine the overall and disease-free survival in patients treated with this regimen
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Determine the incidence of conversion to open thoracotomy in these patients
Determine the short- and long-term complications associated with VAR in these patients
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
OUTLINE This is a multicenter study
Patients undergo video-assisted thoracoscopic wedge resection Surgeons attempt sampling and identification of all ipsilateral mediastinal and hilar lymph nodes When accessible lobar lymph nodes must also be sampled If the tumor margins are positive further resection of the margins must be attempted Open thoracotomy may be required for technical reasons
Determine the feasibility of video-assisted thoracoscopic wedge resection VAR followed by radiotherapy in patients with stage I non-small cell lung cancer and cardiopulmonary dysfunction
Determine the incidence of locoregional recurrence in patients treated with this regimen
Determine the overall and disease-free survival in patients treated with this regimen
Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients
Determine the incidence of conversion to open thoracotomy in these patients
Determine the short- and long-term complications associated with VAR in these patients
Determine the toxicity of adjuvant radiotherapy after VAR in these patients
OUTLINE This is a multicenter study
Patients undergo video-assisted thoracoscopic wedge resection Surgeons attempt sampling and identification of all ipsilateral mediastinal and hilar lymph nodes When accessible lobar lymph nodes must also be sampled If the tumor margins are positive further resection of the margins must be attempted Open thoracotomy may be required for technical reasons
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CDR0000063987 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |