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Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Neoplasms

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Trial Information

Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)


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.


Inclusion Criteria:



- Solid kidney tumor: diameter <= 40mm, maximum volume 32cc

- Intra-parenchymatous localization

- At least one of the following criteria:

- Patient of more than 70 years old

- Hereditary kidney cancer (von Hippel-Lindau Disease disease, hereditary
tubulopapillary carcinoma...)

- Single kidney, with tumor difficult to reach to a conservative surgery
(central-hilar or intra-parenchymatous tumour...)

- Context of local recurrence after partial kidney surgery

- Patient with impaired renal function (renal clearance < 30 ml/min)

- Written informed consent

Exclusion Criteria:

- Conservative surgery feasible in good technical and carcinological conditions

- Contra-indication to either treatment

- Kidney cancer metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Carcinologic efficacy at the site of treatment,

Outcome Time Frame:

at 5 years

Principal Investigator

Nicolas Grenier, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

9359-03

NCT ID:

NCT00221728

Start Date:

April 2005

Completion Date:

January 2008

Related Keywords:

  • Kidney Neoplasms
  • Kidney Neoplasms
  • Surgery
  • Catheter Ablation
  • Randomized controlled trials
  • Kidney Failure, Chronic
  • Neoplasms
  • Kidney Neoplasms

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