Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003724
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-11-01
Brief Title:
Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Randomized Prospective Trial of Open Versus Minimally Invasive Video-Assisted Resection of Pulmonary Metastases
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 may have fewer side effects than conventional surgery in patients with lung metastases It is not yet known whether conventional surgery or video-assisted surgery is more effective in treating lung metastases
PURPOSE Randomized phase III trial to compare the effectiveness of conventional surgery with that of video-assisted surgery in treating patients who have lung metastases
PURPOSE Randomized phase III trial to compare the effectiveness of conventional surgery with that of video-assisted surgery in treating patients who have lung metastases
Detailed Description:
OBJECTIVES I Compare the overall survival and failure free survival of patients with isolated pulmonary metastases treated with minimally invasive video assisted resection or open resection II Compare patterns of recurrence in these patients after these treatments and determine what factors are predictive of recurrence III Describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy in these patients IV Test whether the patients undergoing video-assisted thoracic surgery will have a significantly better quality of life over a six month period than those undergoing an open resection
OUTLINE This is a randomized study Patients are stratified according to histology sarcoma vs epithelial vs germ cell vs melanoma and disease laterality After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery VATS resection with curative intent patients are randomized to undergo either open resection thoracotomy median sternotomy or bilateral sternothoracotomy arm I or minimally-invasive video-assisted resection arm II Patients with isolated recurrence in the chest should have the recurrences resected if feasible The original resection approach open versus VATS should be the preferred method for the second resection but is not required Quality of life is assessed prior to randomization and then at 30 days 3 months and 6 months Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL There will be 530 patients accrued into this study in approximately 3 years
OUTLINE This is a randomized study Patients are stratified according to histology sarcoma vs epithelial vs germ cell vs melanoma and disease laterality After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery VATS resection with curative intent patients are randomized to undergo either open resection thoracotomy median sternotomy or bilateral sternothoracotomy arm I or minimally-invasive video-assisted resection arm II Patients with isolated recurrence in the chest should have the recurrences resected if feasible The original resection approach open versus VATS should be the preferred method for the second resection but is not required Quality of life is assessed prior to randomization and then at 30 days 3 months and 6 months Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL There will be 530 patients accrued into this study in approximately 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 |
|---|---|---|---|
| CDR0000066833 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-39804 | None | None | None |