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Study 4 of 241 for search of: | Open Studies | "Kidney Neoplasms" |
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Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00221728 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Neoplasms |
Device: Radiofrequency Procedure: conservative surgery |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial) |
Estimated Enrollment: | 160 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2011 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following criteria:
Exclusion Criteria:
Contact: Nicolas Grenier, Professor | nicolas.grenier@chu-bordeaux.fr |
France | |
Service de radiologie B, Hôpital Pellegrin | Recruiting |
Bordeaux, France, 33076 | |
Contact: Nicolas Grenier, Professor (33) 5 56 79 55 99 nicolas.grenier@chu-bordeaux.fr | |
Principal Investigator: Nicolas Grenier, Professor |
Principal Investigator: | Nicolas Grenier, Professor | University Hospital, Bordeaux |
Principal Investigator: | Arnaud Méjean, Professor | Hôpital Necker, Paris |
Study Chair: | Paul Perez, Dr | University Hospital, Bordeaux |
Study ID Numbers: | 9359-03, 2003-006 |
Study First Received: | September 13, 2005 |
Last Updated: | June 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00221728 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Kidney Neoplasms Surgery Catheter Ablation Randomized controlled trials Kidney Failure, Chronic |
Urologic Diseases Kidney Neoplasms Kidney Failure, Chronic Urogenital Neoplasms Renal cancer |
Kidney Diseases Kidney cancer Urologic Neoplasms Urinary tract neoplasm Kidney Failure |
Neoplasms Neoplasms by Site |