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Study to assess the efficacy of sorafenib in resected metastatic renal cell cancer.

A randomized, open label, multicenter phase 2 study, to evaluate the efficacy of Sorafenib in patients with advanced Renal Cell Carcinoma (RCC) after a radical resection of the metastases. - RESORT TRIAL

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000708-14-IT
Enrollment
Unknown
Registered
2012-09-03
Start date
2012-10-05
Completion date
Unknown
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced metastatic resected renal cell carcinoma MedDRA version: 15.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: NEXAVAR*112CPR RIV 200MG Pharmaceutical Form: Tablet Current Sponsor code: BAY 43-9006 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name:

Sponsors

ISTITUTO NAZIONALE PER LA CURA TUMORI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Hystological diagnosis of RCC Metastases radically resected Clear cell hystotypes Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 132 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Metastases non radically resected Age less than 18 years Non clear cells histotypes

Design outcomes

Primary

MeasureTime frame
Main Objective: Recurrence free survival;Secondary Objective: Overall survival, safety and tollerability.;Primary end point(s): Recurrence free survival;Timepoint(s) of evaluation of this end point: 12 weeks—

Secondary

MeasureTime frame
Secondary end point(s): Overall survival,safety;Timepoint(s) of evaluation of this end point: 12 weeks—

Countries

Italy

Contacts

Public ContactOncologia Medica I

Fondazione IRCCS Istituto Nazionale dei Tumori

giuseppe.procopio@istitutotumori.mi.it0223903066

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026