Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221728
Status:
TERMINATED
Last Update Posted:
2010-05-28
First Post:
2005-09-13
Brief Title:
Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Treatment of Renal Tumors With Radiofrequency Efficacy Evaluation in Comparison With Conservative Surgery Multicentric Randomized Trial
Status:
TERMINATED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment Mini-invasive thermotherapy as radiofrequency RF induces necrosis of tumoral tissue while sparing normal renal parenchyma The purpose of the study is to compare in patients at risk of renal insufficiency a strategy based on surgical approach and a strategy based on RF approach 180 patients from 9 centers will be randomized in two groups surgical vs RF delivered either percutaneously or under laparoscopy The proportion of patients with a local carcinologic efficacy at 5 years and the general and renal tolerance will be analysed and compared between both strategies
Detailed Description:
Background Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment Mini-invasive thermotherapy as radiofrequency RF induces necrosis of tumoral tissue while sparing normal renal parenchyma
Objectives The main objective is to assess the 5-year local carcinologic efficacy no residual tumor tissue and no recurrence at the site of treatment of the radiofrequency treatment Secondary objectives are to assess 5-year overall carcinologic efficacy predictive factors of technical success of RF procedures and the general and renal tolerance 5 years after treatment
Study design Open label randomized parallel-group multicentric clinical trial 9 centers
Eligibility criteria Patients with renal tumor in whom a surgical treatment may result in renal function impairment
Intervention
Experimental group radiofrequency treatment percutaneous or under laparoscopy using RF 3000 generator Radiotherapeutics Boston scientific under a standardized heating protocol A second procedure is allowed in case of residual tumoral tissue or tumor recurrence
Control group conservative kidney surgery
Outcomes The principal outcome is the 5-year local carcinologic efficacy no residual tumor tissue and no recurrence at the site of treatment as assessed by tomodensitometry or MRI after injection Secondary outcomes are 5-year overall carcinologic efficacy local efficacy and no metastases renal function technical success of RF procedures no residual tumor tissue 2 months after procedure and tolerance
Follow-up Clinical biological and imaging follow-ups are scheduled 2 months 6 months 1 2 3 4 and 5 years after the first treatment
Objectives The main objective is to assess the 5-year local carcinologic efficacy no residual tumor tissue and no recurrence at the site of treatment of the radiofrequency treatment Secondary objectives are to assess 5-year overall carcinologic efficacy predictive factors of technical success of RF procedures and the general and renal tolerance 5 years after treatment
Study design Open label randomized parallel-group multicentric clinical trial 9 centers
Eligibility criteria Patients with renal tumor in whom a surgical treatment may result in renal function impairment
Intervention
Experimental group radiofrequency treatment percutaneous or under laparoscopy using RF 3000 generator Radiotherapeutics Boston scientific under a standardized heating protocol A second procedure is allowed in case of residual tumoral tissue or tumor recurrence
Control group conservative kidney surgery
Outcomes The principal outcome is the 5-year local carcinologic efficacy no residual tumor tissue and no recurrence at the site of treatment as assessed by tomodensitometry or MRI after injection Secondary outcomes are 5-year overall carcinologic efficacy local efficacy and no metastases renal function technical success of RF procedures no residual tumor tissue 2 months after procedure and tolerance
Follow-up Clinical biological and imaging follow-ups are scheduled 2 months 6 months 1 2 3 4 and 5 years after the first treatment
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 |
|---|---|---|---|
| 2003-006 | None | None | None |