Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002473
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
1999-11-01
Brief Title:
Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Prospective Randomized Phase III Study Comparing Radical Surgery to Elective Kidney Sparing Surgery for Low Stage Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Kidney-sparing surgery is a less invasive type of surgery for kidney cancer and may have fewer side effects and improve recovery It is unknown whether kidney-sparing surgery is more effective than kidney removal in treating kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to completely remove the kidney with kidney-sparing surgery in treating patients with resectable kidney cancer
Detailed Description:
OBJECTIVES
Compare time to recurrence and survival of patients with single low stage nonmetastatic well localized and well delineated renal cell cancer treated with partial vs radical resection
Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients
Study the relationship between tumor size histologic grade histologic type and the extent of local control following partial resection
Determine which prognostic factors are important in selecting candidates for conservative surgery
OUTLINE This is a randomized multicenter study
Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy arm I or conservative surgery arm II
Patients are followed every 3 months for 1 year every 4 months for 2 years every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study over 8 years
Compare time to recurrence and survival of patients with single low stage nonmetastatic well localized and well delineated renal cell cancer treated with partial vs radical resection
Establish the side effects of kidney-sparing tumor resection in terms of morbidity and mortality in these patients
Study the relationship between tumor size histologic grade histologic type and the extent of local control following partial resection
Determine which prognostic factors are important in selecting candidates for conservative surgery
OUTLINE This is a randomized multicenter study
Patients are randomized to undergo radical nephrectomy and limited lymphadenectomy arm I or conservative surgery arm II
Patients are followed every 3 months for 1 year every 4 months for 2 years every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study over 8 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 |
|---|---|---|---|
| EORTC-30904 | None | None | None |
| ACOSOG-30904 | None | None | None |
| CAN-NCIC-RE1 | None | None | None |
| E-30904 | None | None | None |
| SWOG-EORTC-30904 | None | None | None |